The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Ankylos Temporary Abutment Balance.
Device ID | K073073 |
510k Number | K073073 |
Device Name: | ANKYLOS TEMPORARY ABUTMENT BALANCE |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
Contact | Helen Lewis |
Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-31 |
Decision Date | 2008-02-12 |
Summary: | summary |