The following data is part of a premarket notification filed by Nobel Biocare Usa, Llc with the FDA for Goldadapt Non-engaging Nobelactive Np & Rp, Goldadapt Engaging Nobelactive Np & Rp.
| Device ID | K083100 |
| 510k Number | K083100 |
| Device Name: | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-20 |
| Decision Date | 2008-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747087970 | K083100 | 000 |
| 07332747087963 | K083100 | 000 |
| 07332747032451 | K083100 | 000 |
| 07332747032444 | K083100 | 000 |
| 07332747032437 | K083100 | 000 |
| 07332747032420 | K083100 | 000 |