Quick facts
- United States: a noble metal alloy is reached through 21 CFR 872.3060, described as a device "composed primarily of noble metals, such as gold, palladium, platinum, or silver", and placed in Class II (special controls).
- United States: a base metal alloy is a separate entry at 21 CFR 872.3710, "composed primarily of base metals, such as nickel, chromium, or cobalt", also Class II with special controls.
- United States: both entries name their special control as a specific FDA guidance document, and both were published at [69 FR 51766, August 23, 2004].
- United States: a preformed crown is reached through 21 CFR 872.3330 and is placed in Class I, which shows that the class follows the material and the use rather than the finished shape.
- Both countries: the material specification for the alloy sits in ISO 22674:2016, and the ceramic side sits in ISO 6872:2015, while ISO 9693-1:2012 states that it does not apply to metallic materials or ceramics used alone.
- The regulation and standard texts cited here were retrieved 2026-10-03; the Canadian regulation text is current to 2026-09-21.
A dental laboratory bench holds alloys, ceramics, waxes, investments and model materials, and the finished crown that leaves it is a combination of two of them. The framework treats the alloy and the ceramic as separate device types with separate standards, and the test that most people assume covers both is written for the pair rather than for either part. That is the fact a specification sheet gets wrong when it cites one standard for a metal-ceramic restoration.
Are noble and base metal alloys two device types?
In the United States, yes, and each carries its own named special control.
21 CFR 872.3060 describes a noble metal alloy as "composed primarily of noble metals, such as gold, palladium, platinum, or silver", intended "for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations". Its class is Class II with special controls, and the entry names the special control as the FDA "Class II Special Controls Guidance Document: Dental Noble Metal Alloys".
21 CFR 872.3710 describes a base metal alloy as "composed primarily of base metals, such as nickel, chromium, or cobalt", intended for the same class of restorations. Its class is the same, its special control is a second named guidance, and both entries carry the same publication history at 69 FR 51766.
The split matters because the metal decides which guidance a laboratory cites. A laboratory that works in both noble and base alloys is working with two device types, and a supplier question about a substitution touches one type rather than the category.
| Item | Canada | United States |
|---|---|---|
| Named entry for a noble alloy | None in Schedule 1 | 872.3060, Class II special controls |
| Named entry for a base alloy | None | 872.3710, Class II special controls |
| Special control | Not named in the instrument | A named FDA guidance per entry |
| Preformed crown | Reached by the general rules | 872.3330, Class I |
| Publication history | Not applicable | 69 FR 51766, August 23, 2004 |
Does the metal-ceramic test apply to a metal alone?
No, and the standard says so in its Scope.
ISO 9693-1:2012 addresses the compatibility of metallic and ceramic materials by testing the composite structure, and its Scope states that it is "not applicable to either metallic materials or ceramics when used alone". The standard is written for the joint, so a laboratory that tests a metal on its own and cites this standard is citing a document whose Scope excludes that use.
The materials on their own have their own standards. ISO 22674:2016 covers metallic materials, including their classification, requirements, and packing, marking and instructions for use, and it applies to materials sold for third-party resale as well as to those used in-house. ISO 6872:2015 covers dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.
A specification sheet that names all three standards is precise: one for the alloy, one for the ceramic and one for the joint. A sheet that names only the joint standard has left the two materials unspecified.
| Material or combination | Standard | What it covers |
|---|---|---|
| Metal alone | ISO 22674:2016 | Classification, requirements, packing and marking |
| Ceramic alone | ISO 6872:2015 | Requirements and test methods for ceramic materials |
| Metal and ceramic together | ISO 9693-1:2012 | Compatibility by testing the composite structure |
| Preformed crown | 21 CFR 872.3330 | Class I device entry in the United States |
Why is a preformed crown Class I when a crown alloy is Class II?
Because the entry describes the material and its route of manufacture, and the class follows that description rather than the finished object.
21 CFR 872.3330 covers a preformed crown, and the entry places it in Class I with a premarket notification exemption. The alloy that a laboratory casts into a crown is a different device, reached through 872.3060 or 872.3710, and it is Class II with special controls. The same clinic receives both, and they arrive in different classes.
Canada does not split the two by name. Schedule 1 to the Medical Devices Regulations reaches a dental material through the general rules, and Rule 3 places denture materials and orthodontic appliances and their accessories in Class II while placing surgical or dental instruments in Class I. A laboratory material that is neither an instrument nor a denture material is described by its intended use.
For the buyer, the practical consequence is that a laboratory purchase order can contain items in two classes, and the file should say which is which rather than assigning one class to the order.
What has to be recorded for a laboratory material?
Six records, and the two that most often go missing are the material standard and the packing information.
- The material and its standard. The alloy and the ceramic recorded separately, each against its own standard, with the joint standard added where the two are tested as a pair.
- The batch and the certificate. The manufacturer's certificate kept per batch, because a material substitution is a different device with a different guidance.
- The packing and instructions. The packing, marking and instructions for use, which the metal standard requires and which a laboratory needs for traceability.
- The class and its route. The section or rule that gives the class for each item on the order.
- The restoration identification. Which material was used for which restoration, so a remake uses the same material.
- The reprocessing record. Which items were reused, with the cycle and monitoring result for each, since laboratory items follow the same reprocessing rules as chairside items.
Which consumables does a laboratory bench restock?
A laboratory bench consumes barriers and handling items alongside the materials. For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. The dental bibs cover the bench surface, the cotton rolls cover moisture control during try-in, and a laboratory that also runs its own steriliser can pair the monitoring collection with the biological indicator 5-pack trial.
Sources
- 21 CFR 872.3060, noble metal alloy
- 21 CFR 872.3710, base metal alloy
- 21 CFR 872.3330, preformed crown
- 21 CFR 872.3690, tooth shade resin material
- 21 CFR 872.3770, temporary crown and bridge resin
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- ISO 22674:2016, metallic materials for restorations
- ISO 6872:2015, dental ceramic materials
- ISO 9693-1:2012, metal-ceramic compatibility
- ISO 4049:2019, polymer-based restorative materials
- ISO 4823:2021, elastomeric impression materials
- ISO 17664-1:2021, information for reprocessing
- ISO 13485:2016, medical device quality management systems
- ISO 14971:2019, risk management of medical devices
- Royal College of Dental Surgeons of Ontario
- Health Canada, medical devices
- Health Canada, drug and health product portal
- openFDA device classification API
- World Health Organization, oral health
- CCOHS, OSH answers
A laboratory material file is only as strong as the batch it points to. The printable material and batch log is a free sheet with a column for the material standard and a column for the manufacturer certificate, so an alloy and a ceramic never share one line. The generator sized to a laboratory bench builds the sheet from the number of units a laboratory produces and the materials it holds, which keeps a small laboratory from being handed a production-line form. No account and no sign-up are needed to open either one.
Where the class of a material or the scope of a standard needs to be explained for a supplier question, the written answer is the one worth having. Ask a compliance specialist and a written answer comes back specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Dental Lab Supplies in Canada: A Procurement Checklist for Labs
- Dental Crown Materials in Canada vs the US: Which Material and Class
- Dental Lab Disinfection: Cleaning Impressions Without Damage
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for dental laboratory, infection control and procurement professionals and is not safety or regulatory guidance; the acceptance of a material and its documentation belong to the laboratory's quality system and to the requirements that apply to it.
Frequently Asked Questions
Are noble metal alloys and base metal alloys the same device type?
In the United States they are two entries. Section 872.3060 covers the noble metal alloy and section 872.3710 covers the base metal alloy, and each names its own FDA guidance document as the special control.
Does ISO 9693-1 apply to a metal used alone?
No. The Scope states that the standard is not applicable to either metallic materials or ceramics when used alone, because it addresses compatibility by testing the composite structure.
What standard covers a metal on its own?
ISO 22674:2016 covers metallic materials, including their classification, requirements, and packing, marking and instructions for use, and it applies to materials sold for third-party resale.
Why is a preformed crown Class I when a crown alloy is Class II?
Section 872.3330 describes the preformed crown as a Class I device, while the alloy used to cast a crown is reached through 872.3060 or 872.3710 as a Class II device with special controls. The class follows the entry's description rather than the finished object.
How are dental laboratory materials classified in Canada?
There is no named entry for an alloy. Rule 3 places denture materials and orthodontic appliances and their accessories in Class II and surgical or dental instruments in Class I, and a material that is neither is described by its intended use under the general rules.
Which records should a laboratory material file keep?
Keep the material and its standard, the batch and the manufacturer certificate, the packing and instructions for use, the class and its route for each item on the order, the restoration identification, and the reprocessing record for reused items.
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