The following data is part of a premarket notification filed by Brontes Technologies with the FDA for 3m Unitek Lava Chairside Oral Scanner.
| Device ID | K081961 |
| 510k Number | K081961 |
| Device Name: | 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER |
| Classification | System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations |
| Applicant | BRONTES TECHNOLOGIES 20310 SW 48TH ST. Southwest Ranches, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum BRONTES TECHNOLOGIES 20310 SW 48TH ST. Southwest Ranches, FL 33332 |
| Product Code | NOF |
| CFR Regulation Number | 872.3661 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-09 |
| Decision Date | 2008-09-05 |
| Summary: | summary |