Quick facts
- An intraoral scanner is a handheld camera that captures the shape of the teeth and the soft tissue so that a restoration or an appliance can be designed from a digital model rather than from a physical impression.
- United States: the system is reached as an optical impression system for CAD/CAM at 21 CFR 872.3661, placed in Class II; the openFDA classification API lists it under product code NOF.
- Canada: the scanner is an active diagnostic device that supplies energy for the purpose of imaging, so it reaches Class II through Rule 10(1) of Schedule 1 to the Medical Devices Regulations, SOR/98-282.
- The two countries land on the same class by different machinery: the United States names the system and Canada reaches it through the active-diagnostic rule.
- The scan is the record, so the file and the model it exports carry the same traceability duty as a physical impression.
- The entry and rule text below were checked against the current CFR text and the Regulations on 2026-10-08.
An intraoral scanner is the camera that replaced the tray of alginate for a growing share of restorative work. It shines structured light or a pattern onto the teeth and builds a three-dimensional model from what comes back, and the model is what the laboratory or the mill works from. It is an active device that supplies energy to image the mouth, and that single fact fixes its class in Canada. This article sets out what the scanner does, how each country files it, and what a practice should be able to point at when the scanner is bought and when the scan file is sent.
What does an intraoral scanner do?
The scanner projects a pattern onto the teeth and reads how it deforms, and it stitches the frames into a model of the arch. The operator watches the coverage on a screen and fills the gaps before the scan is closed. The model is then exported to a design step, where a crown, an appliance or an aligner is built to it rather than to a poured stone model.
Because the scanner supplies energy to image the mouth, it is an active diagnostic device rather than a passive instrument. That is the fact the Canadian rule acts on, and it is why the scanner and a hand instrument do not share a class even though both are used at the same chair.
How does the United States file an intraoral scanner?
In the United States the system is reached by a named entry. 21 CFR 872.3661 covers an optical impression system for computer-assisted design and manufacturing of dental restorations, and the section places it in Class II. The openFDA classification API lists it under product code NOF at Class II. A Class II device of this kind reaches the market under general and special controls.
An intraoral camera used only for images, without the design and manufacturing step, sits beside the scanner as a related article. A practice comparing a scanner with a camera is comparing two entries rather than one device and its part.
Why does Canada reach Class II by rule?
Canada does not keep a named entry for the scanner. It classifies it through the active-device rules in Schedule 1. Rule 10(1) puts an active diagnostic device, including any dedicated software, that supplies energy for the purpose of imaging or monitoring physiological processes in Class II. A scanner supplies light to image the mouth, so it falls to that rule. Rule 10(2) lifts the class to Class III where the device is intended to monitor, assess or diagnose a disease or an abnormal state and an erroneous reading could result in immediate danger, which does not describe a restorative scan.
The software matters to the class rather than sitting outside it. Rule 10(1) reaches dedicated software, so the module that turns the frames into a model is part of the device the rule classifies, and a practice that treats the software as an accessory is treating part of the device as something else.
| Item | Canada | United States |
|---|---|---|
| Class | Class II, by Rule 10(1) | Class II |
| Named entry | No entry names the scanner; it is an active diagnostic device | 21 CFR 872.3661 |
| Basis of the class | The rule that fits a device that images | The named entry the system is filed under |
| Product code | Not applicable | NOF |
| Software | Dedicated software is part of the classified device | Software is part of the system |
| Premarket route | Device licence under section 32 for a Class II device | General and special controls |
| Quality system | CAN/CSA-ISO 13485 certificate behind the licence | Quality system regulation |
The two countries agree on the class and disagree on how they reach it: the United States names the system, and Canada reaches it through the rule for a device that supplies energy to image. A practice that keeps the software version with the scanner record has the document the class implies.
Which standards sit behind the scanner?
The class says how the scanner is regulated; the standards say how it has to behave. ISO 13485:2016 is the quality management basis behind the licence, and ISO 14971:2019 is the risk management basis behind the design file. A practice that asks for those two documents is asking for the evidence behind the accuracy the scanner claims.
| Element | What it covers | Why it matters at the chair |
|---|---|---|
| Accuracy | How close the model is to the mouth | A model off its stated accuracy makes a restoration that does not fit |
| Coverage | Whether the scan is complete | A gap in the scan is a gap in the model |
| Software | The version that builds the model | A version change can shift the model between scans |
| Export | The file sent to the laboratory | A file format the laboratory cannot open is a remake |
| Disinfection | The barrier and the wipe for the wand | The wand is the part that touches the mouth |
| Records | The scan file and its identity | The link between a scan and the restoration made to it |
A scanner that cannot show its last calibration and a scan file that cannot be traced to a case are the two gaps that meet at the same chair.
How is the scan file controlled?
The scan file is the record of the mouth, and it carries the scanner, the software version and the case. A file exported to a laboratory without its software version cannot be reproduced if the model is questioned, and a case without its file cannot be re-made without a new scan. Keeping the three together is what makes a digital impression as traceable as a poured model.
The wand is the part that touches the mouth, so it is disinfected between patients with the barrier and the wipe the maker specifies. The record of that step sits with the scan record rather than apart from it, because the two describe the same appointment and the same patient.
What else sits beside the scanner?
A digital workflow is stocked as a set. A latex dental dam, 6 x 6 in is the isolation the scanner needs to see dry tissue, and a dual-cure self-adhesive resin cement in an automix syringe is the cement the digitally built restoration is seated with. Clinics that monitor their own reprocessing pair the sterilization monitoring collection with the 24-hour biological indicator 50-pack. 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 872.3661, optical impression systems for CAD/CAM
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- US FDA, medical devices
- Health Canada, medical devices
- Standards Council of Canada
- CSA Group
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management of medical devices
- Royal College of Dental Surgeons of Ontario, standards and guidelines
- Canadian Dental Association
- Public Health Ontario, infection prevention and control
- CCOHS, OSH answers
- World Health Organization, oral health
A digital workflow is audited on the file that follows the case. The printable scan and restoration log is a blank sheet with columns for the patient, the tooth, the scanner, the software version, the file and the operator, so a scan can be reconciled with the restoration made to it.
The scan log generator on the same page sizes the sheet to the number of chairs and scanners a practice runs, so a single-chair office and a multi-site group print the form at the volumes they need.
Every practice and every scanner differs. 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
- Dental impression materials in Canada vs the US: which class
- Dental crown materials in Canada vs the US: which material and class
- Dental bonding agents in Canada vs the US: which class
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 practice belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
What class is an intraoral scanner in Canada?
It is Class II under Rule 10(1) of Schedule 1, which covers an active diagnostic device that supplies energy for the purpose of imaging or monitoring physiological processes.
What class is an intraoral scanner in the United States?
It is a named entry at 21 CFR 872.3661 as an optical impression system for CAD/CAM in Class II, and the openFDA classification API lists it under product code NOF.
Do the two countries agree on the class?
Yes. The scanner is Class II in the United States and Class II in Canada, reached by a named entry on one side and by the active-diagnostic rule on the other.
Is the scanner software a separate device?
In Canada, Rule 10(1) reaches dedicated software, so the module that builds the model is part of the classified device. A practice that treats the software as an accessory treats part of the device as something else.
When would a scanner become Class III in Canada?
Rule 10(2) lifts an active diagnostic device to Class III where it is intended to monitor, assess or diagnose a disease or an abnormal state and an erroneous reading could result in immediate danger, which does not describe a restorative scan.
Does a scan need the same records as an impression?
The scan is the record. Keeping the file, the software version and the case identity together is the digital equivalent of keeping a poured model with its case.
Why does the class not follow the accuracy of the scanner?
The class follows the rule path. Rule 10(1) reaches a device that supplies energy to image, and the accuracy of the model is a property the standards and the manufacturer's claims address.
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