Quick facts
- An endodontic paper point is a named Class I entry in the United States at 21 CFR 872.3830 under product code EKN.
- The US entry is exempt from premarket notification subject to the limits in 21 CFR 872.9, so the point reaches the market without a 510(k) review.
- Canada names no paper point. Rule 3(b) of the Medical Devices Regulations puts all surgical or dental instruments in Class I.
- A point that is placed in a root canal and then removed is not an implant, so it is not caught by the implant Schedule or by the long-term rules.
- The point is therefore Class I on both sides of the border, but the reason to keep the paper point separate from the filling point next to it is a real one.
- The regulation text quoted here is current to 2026-09-21 and was last amended on 2026-06-17.
An endodontic paper point is a slim, absorbent paper cone that a dentist seats in a prepared root canal to dry it or to carry medicament down the canal. It is used and discarded within a single visit. It enters the tooth, but it does not stay, and that is why it sits far below the class of the filling that follows it.
What is an endodontic paper point?
The United States describes the device in its own words. Under 21 CFR 872.3830, an endodontic paper point is a device made of paper intended for use during endodontic therapy to dry, or apply medication to, the root canal of a tooth.
Three things in that sentence matter. The material is paper, which means the point is matched by size and taper to the prepared canal. The use is to dry the canal or to carry medication into it. And the point is a temporary aid during therapy, not a permanent filling; it is removed before the canal is filled. Its neighbour, the endodontic silver point that fills the canal, is a separate entry at 21 CFR 872.3840, and gutta percha is another at 21 CFR 872.3850.
How do Canada and the United States classify an endodontic paper point?
The point is Class I in both countries, from two different directions.
| Item | Canada | United States |
|---|---|---|
| Endodontic paper point | Class I by Rule 3(b) | Class I, 21 CFR 872.3830 |
| Basis named in the rulebook | Whether the device is a dental instrument | A named entry and product code (EKN) |
| What decides the class | That it is an instrument rather than an appliance or implant | Which named entry it is filed under |
| Root canal filling material | Depends on the named entry | Gutta percha is a separate entry |
| US premarket route | Not applicable | Exempt from 510(k) subject to § 872.9 |
In the United States the paper point is a named entry, and a product filed under that entry is Class I and exempt from premarket notification subject to the limits in section 872.9. In Canada the point is not named. Rule 3 overrides the surgical and invasive rules and sets out three categories: denture materials and orthodontic appliances in Class II, surgical or dental instruments in Class I, and latex condoms in Class II. An endodontic paper point is an instrument used during dental therapy, so it takes Rule 3(b) and lands in Class I.
That is the part that catches people out. The fact that the point goes into a root canal does not by itself push it into a high class, because Rule 3(b) is written to cover dental instruments as a group.
Why does a point that enters the canal stay in Class I in Canada?
Because the Regulations classify a dental instrument as an instrument, and separately classify the implants and long-term devices that stay in the body.
Rule 3(b) puts all surgical or dental instruments in Class I. That is a deliberate override: even an instrument that is placed into the tooth is an instrument. The long-term rules, which lift a device to Class III when it is intended to remain in the body for at least 30 consecutive days, do not apply to a paper point, because the point is removed at the same visit. Nor is a paper point an implant; Schedule 2 lists the small set of devices treated as implants, such as heart valves and joint replacements, and a paper point is not among them.
The design rule is easy to state: ask whether the item stays in the body, then read Rule 3 and the implant Schedule. A point that is seated, used and removed is described differently from a filling that stays in the canal. That is why the size and the taper of a paper point are matched to the prepared canal rather than to a patient: the point is a bench-to-canal instrument, not a long-term implant.
Which licence and records differ between Canada and the United States?
For a supplier the class is not a label; it decides which paperwork has to exist before the point can be sold.
In the United States the paper point is a Class I entry exempt from premarket notification subject to section 872.9. In Canada a Class I device is not licensed device by device; the manufacturer holds an establishment licence under section 45 of the Regulations and keeps the records the Regulations require. A Class II or higher device instead needs a medical device licence under section 32 supported by a quality-system certificate against ISO 13485. The paper point sits on the lighter tier on both sides, while some of the materials used alongside it in the same canal do not.
What do the two rulebooks actually say?
The two texts are short, and the difference between them is the whole point of this article.
| Rule or entry | Verbatim wording | Effect on an endodontic paper point |
|---|---|---|
| Rule 3(b), Canada | all surgical or dental instruments are classified as Class I | Class I |
| Rule 3(a), Canada | all denture materials and orthodontic appliances … are classified as Class II | Does not apply, because a paper point is an instrument |
| Rule 1(3), Canada | normally intended to remain in the body for at least 30 consecutive days … Class III | Does not apply, because the point is removed |
| Schedule 2, Canada | Implants (heart valve, annuloplasty ring, and others) | A paper point is not an implant |
| 21 CFR 872.3830, US | Endodontic paper point | Named Class I entry, product code EKN |
Read together, the five lines explain why a supplier cannot move the class by relabelling. A filling described as a drying point, while it is left in the canal, is described against the text, not against the product.
Which consumables does an endodontic tray restock?
A tray that runs a root canal runs on the same supplies as any other operatory. The medium cotton rolls isolate the tooth and soak the rinse during the canal prep, and the white saliva ejector tips keep the field clear while the canal is dried. A clinic that also monitors its own steriliser pairs the sterilization monitoring collection with the 24-hour monitoring five-pack trial. Clinics and multi-site groups ordering at case level use the wholesale ordering page, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
Sources
- 21 CFR 872.3830, Endodontic paper point
- 21 CFR 872.3840, Endodontic silver point
- 21 CFR 872.3850, Gutta percha
- 21 CFR 872.3810, Root canal post
- Medical Devices Regulations, SOR/98-282, full text
- openFDA device classification API
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management for medical devices
- ISO 6877:2006, dental root-canal obturating points
- Royal College of Dental Surgeons of Ontario
- Canadian Dental Association
- Public Health Ontario, laboratory services test index
- CCOHS, OSH answers
- CLSI, clinical and laboratory standards
- Government of Canada, medical devices guidance
- Standards Council of Canada
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- American Academy of Ophthalmology, eye health
- 21 CFR 872.3150, Articulator
A point that is matched to the canal by size and taper is a point that seats without forcing. The printable endodontic point size and lot log is a blank sheet with columns for the case, the point size, the taper, the lot and the tooth, so a size mismatch is visible before it is seated. The point log generator on the same page sizes the sheet to the number of chairs a clinic runs. No account and no sign-up are needed to open either one.
Every endodontic setup is different. Ask a compliance specialist and you will get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Gutta Percha Points in Canada vs the US: Which Class?
- Dental Burs in Canada vs the US: Which Type and Numbering?
- Dental Handpieces in Canada vs the US: Which Reprocessing Rules?
CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the class of a device and the records kept by a clinic belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
Is an endodontic paper point a Class I device in the United States?
Yes. An endodontic paper point is a named Class I entry at 21 CFR 872.3830, filed under product code EKN and exempt from premarket notification subject to section 872.9.
How does Canada classify the same point?
Canada names no paper point. Rule 3(b) of the Medical Devices Regulations puts all surgical or dental instruments in Class I, and a paper point used during dental therapy is a dental instrument.
Does a point that enters a root canal become a higher class?
No. Rule 3(b) puts dental instruments in Class I, and the long-term rule that lifts a device to Class III applies only where the device is intended to remain in the body for at least 30 consecutive days. A paper point is removed at the same visit.
Is a paper point an implant?
No. Schedule 2 of the Regulations lists the small set of devices treated as implants, such as heart valves and annuloplasty rings. An endodontic paper point is not on that list.
What is the difference between a paper point and a gutta percha point?
The paper point dries the canal or carries medicament and is removed; the gutta percha point fills the canal. They are separate entries at 21 CFR 872.3830 and 21 CFR 872.3850, both Class I.
What does the class change for a supplier?
A Class I device sold in Canada sits under an establishment licence and records rather than a device licence. A Class II device needs a device licence under section 32 supported by a quality-system certificate against ISO 13485.
Does an endodontic paper point need a 510(k) in the United States?
No. The entry at 21 CFR 872.3830 is exempt from premarket notification subject to the limitations in section 872.9.
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