The following data is part of a premarket notification filed by Brontes Technologies with the FDA for 3m Espe Lava Chairside Oral Scanner.
Device ID | K073199 |
510k Number | K073199 |
Device Name: | 3M ESPE 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 | 2007-11-13 |
Decision Date | 2007-12-21 |
Summary: | summary |