The following data is part of a premarket notification filed by Sterngold with the FDA for Sterngold Implamed Narrow Platform Dental Implants And Related Prosthetics And Instrumentation.
| Device ID | K991436 |
| 510k Number | K991436 |
| Device Name: | STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERNGOLD 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
| Contact | Gordon Nelson |
| Correspondent | Gordon Nelson STERNGOLD 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08415491067456 | K991436 | 000 |
| 00841549111709 | K991436 | 000 |
| 00841549111693 | K991436 | 000 |
| 00841549114007 | K991436 | 000 |
| 00841549113994 | K991436 | 000 |
| 00841549114977 | K991436 | 000 |
| 00841549114960 | K991436 | 000 |
| 00841549114953 | K991436 | 000 |
| 00841549114946 | K991436 | 000 |
| 00841549114939 | K991436 | 000 |
| 00841549111716 | K991436 | 000 |
| 00841549111723 | K991436 | 000 |
| 00841549113970 | K991436 | 000 |
| 08415491067425 | K991436 | 000 |
| 08415491067289 | K991436 | 000 |
| 08415491067258 | K991436 | 000 |
| 08415491039873 | K991436 | 000 |
| 08415491039767 | K991436 | 000 |
| 08415491039750 | K991436 | 000 |
| 08415491039743 | K991436 | 000 |
| 08415491039446 | K991436 | 000 |
| 00841549113987 | K991436 | 000 |
| 00841549108440 | K991436 | 000 |