The following data is part of a premarket notification filed by Kj Meditech with the FDA for Anchor Plus/neo Anchor Plus.
| Device ID | K053629 |
| 510k Number | K053629 |
| Device Name: | ANCHOR PLUS/NEO ANCHOR PLUS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | KJ MEDITECH 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack KJ MEDITECH 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-29 |
| Decision Date | 2006-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809488210251 | K053629 | 000 |
| 08809488210145 | K053629 | 000 |
| 08809488210138 | K053629 | 000 |
| 08809488210121 | K053629 | 000 |
| 08809488210114 | K053629 | 000 |
| 08809488210107 | K053629 | 000 |
| 08809488210091 | K053629 | 000 |
| 08809488210084 | K053629 | 000 |
| 08809488210077 | K053629 | 000 |
| 08809488210152 | K053629 | 000 |
| 08809488210169 | K053629 | 000 |
| 08809488210244 | K053629 | 000 |
| 08809488210237 | K053629 | 000 |
| 08809488210220 | K053629 | 000 |
| 08809488210213 | K053629 | 000 |
| 08809488210206 | K053629 | 000 |
| 08809488210190 | K053629 | 000 |
| 08809488210183 | K053629 | 000 |
| 08809488210176 | K053629 | 000 |
| 08809488210060 | K053629 | 000 |