The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Anodized Healing Collar.
Device ID | K111852 |
510k Number | K111852 |
Device Name: | ANODIZED HEALING COLLAR |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-29 |
Decision Date | 2011-08-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024015128 | K111852 | 000 |
00889024014985 | K111852 | 000 |
00889024014992 | K111852 | 000 |
00889024015005 | K111852 | 000 |
00889024015012 | K111852 | 000 |
00889024015029 | K111852 | 000 |
00889024015036 | K111852 | 000 |
00889024015043 | K111852 | 000 |
00889024015050 | K111852 | 000 |
00889024015067 | K111852 | 000 |
00889024015074 | K111852 | 000 |
00889024015081 | K111852 | 000 |
00889024015098 | K111852 | 000 |
00889024015104 | K111852 | 000 |
00889024015111 | K111852 | 000 |
00889024014978 | K111852 | 000 |