The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Asc-12 Piezoelectric Scaler.
| Device ID | K070866 |
| 510k Number | K070866 |
| Device Name: | ASC-12 PIEZOELECTRIC SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Grant Ramaley |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-29 |
| Decision Date | 2007-04-11 |
| Summary: | summary |