The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for General Denistry Motor.
| Device ID | K103399 |
| 510k Number | K103399 |
| Device Name: | GENERAL DENISTRY MOTOR |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Cherie Tregoning |
| Correspondent | Cherie Tregoning ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-19 |
| Decision Date | 2011-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817417021040 | K103399 | 000 |
| 10817417020128 | K103399 | 000 |
| 10817417020142 | K103399 | 000 |
| 10817417020159 | K103399 | 000 |
| 10817417020784 | K103399 | 000 |
| 10817417020791 | K103399 | 000 |
| 10817417020807 | K103399 | 000 |
| 10817417021002 | K103399 | 000 |
| 10817417021019 | K103399 | 000 |
| 10817417021026 | K103399 | 000 |
| 10817417021033 | K103399 | 000 |
| 10817417020111 | K103399 | 000 |