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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K944256
Device Name OKTAS INTRA-ORAL DENTAL CAMERA
Applicant
Oktas
134 Flanders Rd.
Westborough,  MA  01581
Applicant Contact KEN HORI
Correspondent
Oktas
134 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact KEN HORI
Regulation Number872.6640
Classification Product Code
EIA  
Date Received08/31/1994
Decision Date 11/22/1994
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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