The following data is part of a premarket notification filed by Asi Medical, Inc. with the FDA for Triton Self Contained Dental System, Triton Self Contained Dental System, With Case.
| Device ID | K110481 |
| 510k Number | K110481 |
| Device Name: | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE |
| Classification | Unit, Operative Dental |
| Applicant | ASI MEDICAL, INC. 14550 E EASTER AVE. SUITE 700 Centennial, CO 80112 |
| Contact | John Mcpeek |
| Correspondent | John Mcpeek ASI MEDICAL, INC. 14550 E EASTER AVE. SUITE 700 Centennial, CO 80112 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-18 |
| Decision Date | 2012-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850309007381 | K110481 | 000 |
| 00850309007459 | K110481 | 000 |
| 00850309007442 | K110481 | 000 |
| 00850309007435 | K110481 | 000 |
| 00850309007428 | K110481 | 000 |
| 00850309007411 | K110481 | 000 |
| 00850309007473 | K110481 | 000 |
| 00850309007497 | K110481 | 000 |
| 00850309007763 | K110481 | 000 |
| 00850309007466 | K110481 | 000 |
| 00850309007022 | K110481 | 000 |
| 00850309007374 | K110481 | 000 |
| 00850309007121 | K110481 | 000 |
| 00850309007114 | K110481 | 000 |
| 00850309007107 | K110481 | 000 |
| 00850309007091 | K110481 | 000 |
| 00850309007084 | K110481 | 000 |
| 00850309007060 | K110481 | 000 |
| 00850309007053 | K110481 | 000 |
| 00850309007770 | K110481 | 000 |