FDA 510(k) Application Details - K171922

Device Classification Name Abutment, Implant, Dental, Endosseous

  More FDA Info for this Device
510(K) Number K171922
Device Name Abutment, Implant, Dental, Endosseous
Applicant Buckeye Medical Technologies LLC
405 Niles Cortland Rd SE
Ste 202
Warren, OH 44484 US
Other 510(k) Applications for this Company
Contact Terry B. Philibin
Other 510(k) Applications for this Contact
Regulation Number 872.3630

  More FDA Info for this Regulation Number
Classification Product Code NHA
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/27/2017
Decision Date 09/28/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact