The following data is part of a premarket notification filed by Hr Dental Products Inc with the FDA for Flight Dental Systems A-series Dental Operative Unit.
| Device ID | K070196 |
| 510k Number | K070196 |
| Device Name: | FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT |
| Classification | Unit, Operative Dental |
| Applicant | HR DENTAL PRODUCTS INC 21 KENVIEW BLVD, UNIT 9 Brampton, Ontario, CA L6t 5g7 |
| Contact | Jim Ronalds |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D884A6EP1020 | K070196 | 000 |
| D884A6EP1000 | K070196 | 000 |
| D884A12HP1000 | K070196 | 000 |