The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Angled Tapered Abutment.
Device ID | K111853 |
510k Number | K111853 |
Device Name: | ANGLED TAPERED ABUTMENT |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
Contact | Melissa Burbage |
Correspondent | Melissa Burbage ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-29 |
Decision Date | 2011-12-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024013612 | K111853 | 000 |
00889024012042 | K111853 | 000 |
00889024012059 | K111853 | 000 |
00889024012066 | K111853 | 000 |
00889024012073 | K111853 | 000 |
00889024012080 | K111853 | 000 |
00889024013568 | K111853 | 000 |
00889024013575 | K111853 | 000 |
00889024013582 | K111853 | 000 |
00889024013599 | K111853 | 000 |
00889024013605 | K111853 | 000 |
00889024012035 | K111853 | 000 |