FDA 510(k) Application Details - K933646

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K933646
Device Name Implant, Endosseous, Root-Form
Applicant CAL-FORM, INC.
110 TIMBERCOVE CIR. SOUTH
LONGWOOD, FL 32779 US
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Contact SHARON COATOAM
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 07/27/1993
Decision Date 01/04/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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