The following data is part of a premarket notification filed by Sterngold Dental, Llc with the FDA for Mor Implant System.
| Device ID | K153173 |
| 510k Number | K153173 |
| Device Name: | MOR Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERNGOLD DENTAL, LLC 23 FRANK MOSSBERG DR Attleboro, MA 02703 |
| Contact | Maria Rao |
| Correspondent | Maria Rao STERNGOLD DENTAL, LLC 23 FRANK MOSSBERG DR Attleboro, MA 02703 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-03 |
| Decision Date | 2016-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08415491156280 | K153173 | 000 |
| 00841549108259 | K153173 | 000 |
| 00841549108242 | K153173 | 000 |
| 00841549108235 | K153173 | 000 |
| 00841549108228 | K153173 | 000 |
| 00841549113963 | K153173 | 000 |
| 00841549113659 | K153173 | 000 |
| 00841549113642 | K153173 | 000 |
| 00841549113390 | K153173 | 000 |
| 00841549119149 | K153173 | 000 |
| 00841549115752 | K153173 | 000 |
| 00841549115721 | K153173 | 000 |
| 00841549108266 | K153173 | 000 |
| 00841549108273 | K153173 | 000 |
| 00841549108167 | K153173 | 000 |
| 08415491156273 | K153173 | 000 |
| 08415491156266 | K153173 | 000 |
| 08415491156259 | K153173 | 000 |
| 08415491156242 | K153173 | 000 |
| 08415491156235 | K153173 | 000 |
| 00841549114755 | K153173 | 000 |
| 00841549108211 | K153173 | 000 |
| 00841549108204 | K153173 | 000 |
| 00841549108198 | K153173 | 000 |
| 00841549108181 | K153173 | 000 |
| 00841549108174 | K153173 | 000 |
| 00841549115714 | K153173 | 000 |