The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Rn Synocta Ucla Gold Abutment For The Straumann Dental Implant.
| Device ID | K041295 |
| 510k Number | K041295 |
| Device Name: | RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Contact | John King |
| Correspondent | John King INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-14 |
| Decision Date | 2004-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725486 | K041295 | 000 |
| 07630031724243 | K041295 | 000 |
| 07630031702074 | K041295 | 000 |