3M True Definition Scanner
FDA 510(k) K122467 · 3M Company
Submission
- Device name
- 3M True Definition Scanner
- Applicant
- 3M Company
Saint Paul, MN, US - Received
- August 13, 2012
- Decision date
- November 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- NOF – System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3661
- Specialty
- Dental
An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with…
Other 510(k)s with product code NOF
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|---|---|---|---|
| K141611 | Lythos Digital Impression SystemNOF · Traditional | Ormco Corp. | 12/05/2014SE |
| K122065 | Digital Impression System for Orthodontic UseNOF · Traditional | Ormco Corp. | 02/08/2013SE |
| K081961 | 3M Unitek Lava Chairside Oral ScannerNOF · Traditional | Brontes Technologies | 09/05/2008SE |
| K073199 | 3M Espe Lava Chairside Oral ScannerNOF · Traditional | Brontes Technologies | 12/21/2007SE |
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Questions and answers
When was 3M True Definition Scanner cleared by the FDA?
3M True Definition Scanner (K122467) received a 510(k) decision of Substantially Equivalent on November 20, 2012, 99 days after the submission was received.
What is the product code of K122467?
The FDA product code is NOF – System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations, a Class II (moderate risk) device regulated under 21 CFR 872.3661.