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510(k) K070591

REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH by Union Dental S.A./Unidesa.Odi — Product Code ELM

K070591 is an FDA 510(k) premarket notification submitted by Union Dental S.A./Unidesa.Odi for the device "REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH". The FDA issued a decision of Substantially Equivalent on May 11, 2007. 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
May 11, 2007
Date Received
March 1, 2007
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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  • 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)

FDA data resources