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510(k) K122955

DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM by Wright Health Group , Ltd. — Product Code ELM

K122955 is an FDA 510(k) premarket notification submitted by Wright Health Group , Ltd. for the device "DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM". The FDA issued a decision of Substantially Equivalent on March 1, 2013. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
September 25, 2012
Clearance Type
Abbreviated
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 for product code ELM

  • K132984 — SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S (January 14, 2014)
  • 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)
  • 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)

FDA data resources