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510(k) K101064

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P by Bredent GmbH & Co. KG — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2010
Date Received
April 16, 2010
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

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Other clearances for product code ELM

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  • K122955 — DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM (March 1, 2013)
  • K122925 — NEW STETIC ARTIFICIAL TEETH (February 12, 2013)
  • K122852 — PHYSIOSTAR NFC (December 6, 2012)
  • 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)
  • K101029 — KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYM (August 16, 2010)
  • K093331 — SR PHONARES NHC (January 28, 2010)