The following data is part of a premarket notification filed by Progeny, Inc. with the FDA for Vivid, Models 40-a0001, 40-a0004, 40-a0006.
| Device ID | K090079 |
| 510k Number | K090079 |
| Device Name: | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 |
| Classification | Unit, Operative Dental |
| Applicant | PROGENY, INC. 675 HEATHROW DRIVE Lincolnshire, IL 60069 |
| Contact | Alan Krema |
| Correspondent | Alan Krema PROGENY, INC. 675 HEATHROW DRIVE Lincolnshire, IL 60069 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-12 |
| Decision Date | 2009-05-01 |
| Summary: | summary |