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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K950203
Device Name PROTEMP(R) GARANT
Applicant
Espe GmbH & Co. Kg.
Am Griesberg 2
Seefeld,  DE D-82229
Applicant Contact ANTJE BRECHENMACHER
Correspondent
Espe GmbH & Co. Kg.
Am Griesberg 2
Seefeld,  DE D-82229
Correspondent Contact ANTJE BRECHENMACHER
Regulation Number872.3770
Classification Product Code
EBG  
Date Received01/18/1995
Decision Date 02/02/1995
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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