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510(k) K122852

PHYSIOSTAR NFC by Candulor USA, Inc. — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2012
Date Received
September 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture, Plastic, Teeth
Device Class
Class II
Regulation Number
872.3590
Review Panel
DE
Submission Type

Other clearances by Candulor USA, Inc.

  • K101814 — DIRECT CROWN NATURAL 1 (September 27, 2010)

Other clearances for product code ELM

  • K132984 — SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S (January 14, 2014)
  • K122955 — DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM (March 1, 2013)
  • K122925 — NEW STETIC ARTIFICIAL TEETH (February 12, 2013)
  • K121749 — VERACIA (September 7, 2012)
  • K120404 — MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH (May 21, 2012)
  • K120736 — SR PHONARES II (May 14, 2012)
  • K113426 — VERACIA SA (February 8, 2012)
  • K101064 — BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (September 14, 2010)
  • K101029 — KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYM (August 16, 2010)
  • K093331 — SR PHONARES NHC (January 28, 2010)