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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K950030
Device Name HELIODENT MD
Applicant
Pelton & Crane Co.
P.O. Box 7800
Charlotte,  NC  28241
Applicant Contact KRISTI KUNKEL
Correspondent
Pelton & Crane Co.
P.O. Box 7800
Charlotte,  NC  28241
Correspondent Contact KRISTI KUNKEL
Regulation Number872.1810
Classification Product Code
EAP  
Date Received01/04/1995
Decision Date 02/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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