The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer One-piece Implant, 3.7 Mm, Angled.
Device ID | K061717 |
510k Number | K061717 |
Device Name: | ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED |
Classification | Implant, Endosseous, Root-form |
Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
Contact | Erin Mcvey |
Correspondent | Erin Mcvey ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-19 |
Decision Date | 2006-09-08 |
Summary: | summary |