The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Sterngold Implamed Wide Platform Dental Implants And Related Prosthetics And Insttumentation.
Device ID | K983786 |
510k Number | K983786 |
Device Name: | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION |
Classification | Implant, Endosseous, Root-form |
Applicant | STERNGOLD/IMPLAMED 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
Contact | Chad Patterson |
Correspondent | Chad Patterson STERNGOLD/IMPLAMED 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 | 1998-10-27 |
Decision Date | 1998-11-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08415491067401 | K983786 | 000 |
00841549111372 | K983786 | 000 |
00841549111365 | K983786 | 000 |
00841549114991 | K983786 | 000 |
00841549114984 | K983786 | 000 |
00841549111358 | K983786 | 000 |
00841549111341 | K983786 | 000 |
00841549111334 | K983786 | 000 |
00841549111327 | K983786 | 000 |
00841549111686 | K983786 | 000 |
00841549111679 | K983786 | 000 |
00841549111662 | K983786 | 000 |
00841549114137 | K983786 | 000 |
00841549114144 | K983786 | 000 |
08415491067395 | K983786 | 000 |
08415491067388 | K983786 | 000 |
08415491067371 | K983786 | 000 |
08415491038715 | K983786 | 000 |
08415491038708 | K983786 | 000 |
08415491038647 | K983786 | 000 |
08415491038630 | K983786 | 000 |
08415491038623 | K983786 | 000 |
08415491038616 | K983786 | 000 |
00841549114168 | K983786 | 000 |
00841549114151 | K983786 | 000 |
00841549111655 | K983786 | 000 |