The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Amorphous Diamond Coated Screw.
| Device ID | K992538 |
| 510k Number | K992538 |
| Device Name: | AMORPHOUS DIAMOND COATED SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Kim Rendon |
| Correspondent | Kim Rendon NOBEL BIOCARE UAS INC 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-30 |
| Decision Date | 1999-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747022261 | K992538 | 000 |
| 07332747000245 | K992538 | 000 |
| 07332747000252 | K992538 | 000 |
| 07332747000672 | K992538 | 000 |
| 07332747000689 | K992538 | 000 |
| 07332747000733 | K992538 | 000 |
| 07332747000740 | K992538 | 000 |
| 07332747000764 | K992538 | 000 |
| 07332747000771 | K992538 | 000 |
| 07332747000788 | K992538 | 000 |
| 07332747000795 | K992538 | 000 |
| 07332747000801 | K992538 | 000 |
| 07332747013900 | K992538 | 000 |
| 07332747021417 | K992538 | 000 |
| 07332747022230 | K992538 | 000 |
| 07332747022247 | K992538 | 000 |
| 07332747022254 | K992538 | 000 |
| 07332747000238 | K992538 | 000 |