The following data is part of a premarket notification filed by Athena Technology, Inc. with the FDA for Athena 1:1 Contra Angle, Athena 4:1 Contra Angle, Athena 16:1 Contra Angle, Athena 64:1 Contra Angle, Athena 16-: Contre.
| Device ID | K974670 |
| 510k Number | K974670 |
| Device Name: | ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | ATHENA TECHNOLOGY, INC. 984 NORTH AMELIA AVE. San Dimas, CA 91773 |
| Contact | Wlliam T Anderson |
| Correspondent | Wlliam T Anderson ATHENA TECHNOLOGY, INC. 984 NORTH AMELIA AVE. San Dimas, CA 91773 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-15 |
| Decision Date | 1998-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302730001959 | K974670 | 000 |
| 10302730001935 | K974670 | 000 |
| 10302730001904 | K974670 | 000 |
| 10302730001881 | K974670 | 000 |
| 10302730001874 | K974670 | 000 |
| 10302730001867 | K974670 | 000 |
| 10302730001850 | K974670 | 000 |