The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Airdent Radiance Curing Light.
| Device ID | K982615 |
| 510k Number | K982615 |
| Device Name: | AIRDENT RADIANCE CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11802 |
| Contact | Joseph Carey |
| Correspondent | Joseph Carey AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11802 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-27 |
| Decision Date | 1998-08-24 |