FDA 510(k) Application Details - K011502

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K011502
Device Name Implant, Endosseous, Root-Form
Applicant CRYSTAL-SEAL DENTAL IMPLANTS
181 VALLEY PKWY.
PELHAM,, AL 35124 US
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Contact CLINT FOLSOM
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 05/16/2001
Decision Date 10/22/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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