The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Procera Abutment Octagon.
Device ID | K041275 |
510k Number | K041275 |
Device Name: | PROCERA ABUTMENT OCTAGON |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Contact | Elizabeth J Mason |
Correspondent | Elizabeth J Mason NOBEL BIOCARE UAS INC 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 | 2004-05-12 |
Decision Date | 2004-05-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07332747100419 | K041275 | 000 |
07332747100402 | K041275 | 000 |
07332747099850 | K041275 | 000 |
07332747012361 | K041275 | 000 |
07332747002690 | K041275 | 000 |
07332747000283 | K041275 | 000 |