The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Variobase Abutment Nnc, Straumann Variobase Abutment Rn, Straumann Variobase Abutment Wn, Straumann Variobase Abutment Nc, Straumann Variobase Abutment Rc, Ips E.max Cad Mo Coping, Ips E.max Cad Lt Crown, Ips E.max Cad Ht Crown, Coron Cocr .
| Device ID | K142890 |
| 510k Number | K142890 |
| Device Name: | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS E.max CAD MO Coping, IPS E.max CAD LT Crown, IPS E.max CAD HT Crown, Coron CoCr |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Jennifer M. Jackson |
| Correspondent | Jennifer M. Jackson STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-03 |
| Decision Date | 2015-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031736338 | K142890 | 000 |
| 07630031736192 | K142890 | 000 |
| 07630031701657 | K142890 | 000 |
| 07630031701640 | K142890 | 000 |
| 07630031701633 | K142890 | 000 |
| 07630031701626 | K142890 | 000 |
| 07630031701619 | K142890 | 000 |
| 07630031701602 | K142890 | 000 |
| 07630031701596 | K142890 | 000 |
| 07630031701589 | K142890 | 000 |
| 07630031701572 | K142890 | 000 |
| 07630031701565 | K142890 | 000 |
| 07630031736208 | K142890 | 000 |
| 07630031736215 | K142890 | 000 |
| 07630031736222 | K142890 | 000 |
| 07630031736376 | K142890 | 000 |
| 07630031736369 | K142890 | 000 |
| 07630031736352 | K142890 | 000 |
| 07630031736345 | K142890 | 000 |
| 07630031736321 | K142890 | 000 |
| 07630031736314 | K142890 | 000 |
| 07630031736307 | K142890 | 000 |
| 07630031736260 | K142890 | 000 |
| 07630031736253 | K142890 | 000 |
| 07630031736246 | K142890 | 000 |
| 07630031736239 | K142890 | 000 |
| 07630031701558 | K142890 | 000 |