The following data is part of a premarket notification filed by Sterngold Dental, Llc with the FDA for Mor 3.0mm And Pur Np 3.2mm Implant Systems, Mor 2.1x18mm And 2.4x18mm.
| Device ID | K171728 |
| 510k Number | K171728 |
| Device Name: | MOR 3.0mm And PUR NP 3.2mm Implant Systems, MOR 2.1x18mm And 2.4x18mm |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703 |
| Contact | Maria Rao |
| Correspondent | Maria Rao Sterngold Dental, LLC 23 Frank Mossberg Drive 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 | 2017-06-12 |
| Decision Date | 2017-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841549108310 | K171728 | 000 |
| 00841549108303 | K171728 | 000 |
| 00841549108297 | K171728 | 000 |
| 00841549108280 | K171728 | 000 |