The following data is part of a premarket notification filed by The Emerging Technologies Group with the FDA for Mt-3a.
| Device ID | K961385 |
| 510k Number | K961385 |
| Device Name: | MT-3A |
| Classification | Implant, Endosseous, Root-form |
| Applicant | THE EMERGING TECHNOLOGIES GROUP 824 U.S. HWY. 1, SUITE 370 North Palm Beach, FL 33408 |
| Contact | Jack T Krauser |
| Correspondent | Jack T Krauser THE EMERGING TECHNOLOGIES GROUP 824 U.S. HWY. 1, SUITE 370 North Palm Beach, FL 33408 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-19 |
| Decision Date | 1996-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307122425 | K961385 | 000 |
| 10841307118169 | K961385 | 000 |
| 10841307118176 | K961385 | 000 |
| 10841307118183 | K961385 | 000 |
| 10841307118336 | K961385 | 000 |
| 10841307118343 | K961385 | 000 |
| 10841307118350 | K961385 | 000 |
| 10841307118572 | K961385 | 000 |
| 10841307118589 | K961385 | 000 |
| 10841307118664 | K961385 | 000 |
| 10841307118671 | K961385 | 000 |
| 10841307122418 | K961385 | 000 |
| 10841307117988 | K961385 | 000 |