The following data is part of a premarket notification filed by Straumann Usa with the FDA for Nnc Cementable Abutment Straight,15 Degree Angle, Type A ,15 Degree Angle, Type B,nnc Basal Screw Cementable Abutments.
| Device ID | K113283 |
| 510k Number | K113283 |
| Device Name: | NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-07 |
| Decision Date | 2011-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725363 | K113283 | 000 |
| 07630031725172 | K113283 | 000 |
| 07630031724403 | K113283 | 000 |
| 07630031724090 | K113283 | 000 |
| 07630031724083 | K113283 | 000 |
| 07630031723840 | K113283 | 000 |
| 07630031723833 | K113283 | 000 |
| 07630031723826 | K113283 | 000 |
| 07630031701275 | K113283 | 000 |