FDA 510(k) Application Details - K112333

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K112333
Device Name Abutment, Implant, Dental, Endosseous
Applicant BCF CERTIFICATION INC.
1100 RENE-LEVESQUE BLVD.
WEST, 25TH FLOOR
MONTREAL H4L 2L8 CA
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Contact LOUIS-PAUL MARIN
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 08/12/2011
Decision Date 01/30/2012
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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