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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade-Form Endosseous Dental Implant
510(k) Number K981954
Device Name VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
Applicant
Healthline Implants, Inc.
832 Marseilles-Galion Rd. W
Marion,  OH 
Applicant Contact WILLIAM SIMMONS
Correspondent
Healthline Implants, Inc.
832 Marseilles-Galion Rd. W
Marion,  OH 
Correspondent Contact WILLIAM SIMMONS
Regulation Number872.3640
Classification Product Code
NRQ  
Date Received06/04/1998
Decision Date 01/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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