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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K171922
Device Name Anatotemp Anatomic Dental Implant Healing Abutment
Applicant
Buckeye Medical Technologies LLC
405 Niles Cortland Rd SE
Ste 202
Warren,  OH  44484
Applicant Contact Terry B. Philibin
Correspondent
Buckeye Medical Technologies LLC
405 Niles Cortland Rd SE
Ste 202
Warren,  OH  44484
Correspondent Contact Terry B. Philibin
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/27/2017
Decision Date 09/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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