The following data is part of a premarket notification filed by Impla-med with the FDA for Titanium/stainless Steel Dental Implant Drill Comp.
| Device ID | K902158 |
| 510k Number | K902158 |
| Device Name: | TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLA-MED 13794 N.W. 4TH ST. SUITE 209 Sunrise, FL 33325 |
| Contact | Smolowitz |
| Correspondent | Smolowitz IMPLA-MED 13794 N.W. 4TH ST. SUITE 209 Sunrise, FL 33325 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-15 |
| Decision Date | 1990-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841549114731 | K902158 | 000 |
| 00841549102066 | K902158 | 000 |
| 00841549102059 | K902158 | 000 |
| 00841549102042 | K902158 | 000 |
| 00841549102035 | K902158 | 000 |
| 00841549102080 | K902158 | 000 |
| 00841549115080 | K902158 | 000 |
| 00841549115073 | K902158 | 000 |
| 00841549115066 | K902158 | 000 |
| 00841549115059 | K902158 | 000 |
| 00841549115042 | K902158 | 000 |
| 00841549114922 | K902158 | 000 |
| 00841549114915 | K902158 | 000 |
| 00841549114908 | K902158 | 000 |
| 00841549114892 | K902158 | 000 |
| 00841549114700 | K902158 | 000 |
| 00841549102073 | K902158 | 000 |
| 00841549114427 | K902158 | 000 |
| 00841549114434 | K902158 | 000 |
| 00841549114724 | K902158 | 000 |
| 00841549114717 | K902158 | 000 |
| 00841549114694 | K902158 | 000 |
| 00841549114687 | K902158 | 000 |
| 00841549114670 | K902158 | 000 |
| 00841549114663 | K902158 | 000 |
| 00841549114656 | K902158 | 000 |
| 00841549114649 | K902158 | 000 |
| 00841549114632 | K902158 | 000 |
| 00841549114625 | K902158 | 000 |
| 00841549114618 | K902158 | 000 |
| 00841549114601 | K902158 | 000 |
| 00841549114595 | K902158 | 000 |
| 00841549114588 | K902158 | 000 |
| 00841549114571 | K902158 | 000 |
| 00841549114458 | K902158 | 000 |