The following data is part of a premarket notification filed by Asi Medical, Inc. with the FDA for Advanced Endodontic System- Designer Series.
| Device ID | K123139 |
| 510k Number | K123139 |
| Device Name: | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES |
| Classification | Scaler, Ultrasonic |
| 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 | ELC |
| Subsequent Product Code | DZI |
| Subsequent Product Code | EBZ |
| Subsequent Product Code | EFA |
| Subsequent Product Code | EIA |
| Subsequent Product Code | EKR |
| Subsequent Product Code | EKX |
| Subsequent Product Code | LQY |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-05 |
| Decision Date | 2013-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850309007367 | K123139 | 000 |
| 00850309007237 | K123139 | 000 |
| 00850309007220 | K123139 | 000 |
| 00850309007213 | K123139 | 000 |
| 00850309007206 | K123139 | 000 |
| 00850309007190 | K123139 | 000 |
| 00850309007183 | K123139 | 000 |
| 00850309007176 | K123139 | 000 |
| 00850309007169 | K123139 | 000 |
| 00850309007152 | K123139 | 000 |
| 00850309007145 | K123139 | 000 |
| 00850309007244 | K123139 | 000 |
| 00850309007251 | K123139 | 000 |
| 00850309007350 | K123139 | 000 |
| 00850309007343 | K123139 | 000 |
| 00850309007336 | K123139 | 000 |
| 00850309007329 | K123139 | 000 |
| 00850309007312 | K123139 | 000 |
| 00850309007305 | K123139 | 000 |
| 00850309007299 | K123139 | 000 |
| 00850309007282 | K123139 | 000 |
| 00850309007275 | K123139 | 000 |
| 00850309007268 | K123139 | 000 |
| 00850309007138 | K123139 | 000 |