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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K092248
Device Name SPI CUSTOMIZABLE GINGIVA FORMER
Applicant
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL,
SUITE 200
san diego,  CA  92130
Applicant Contact linda k schulz
Correspondent
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL,
SUITE 200
san diego,  CA  92130
Correspondent Contact linda k schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/28/2009
Decision Date 09/25/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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