The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Zfx Titanium Base Abutment For Tapered Screwvent Implant System.
Device ID | K133551 |
510k Number | K133551 |
Device Name: | ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM |
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 | 2013-11-19 |
Decision Date | 2014-07-18 |
Summary: | summary |