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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K852802
Device Name DENAR DENTAL IMPLANT
Applicant
Denar Corp.
901 E. Cerritos Ave.
Anaheim,  CA  92805
Applicant Contact KEN KRUEGER
Correspondent
Denar Corp.
901 E. Cerritos Ave.
Anaheim,  CA  92805
Correspondent Contact KEN KRUEGER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/03/1985
Decision Date 09/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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