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510(k) K913582

COMPATIT R by Wilde-USA, Inc. — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1993
Date Received
August 12, 1991
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 Wilde-USA, Inc.

  • K915653 — KERAMAIL (April 8, 1993)
  • K913581 — WILDE ADHESIVE BONDING SYSTEM (February 26, 1993)
  • K923472 — COMPACOLOR (October 13, 1992)
  • K920649 — COMPASEP (July 23, 1992)
  • K913089 — WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS (April 21, 1992)
  • K915250 — WIL-PDS & WIL-PDI CASTING ALLOYS (April 21, 1992)
  • K912990 — CONVERBASE (March 25, 1992)
  • K920557 — WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX (March 20, 1992)
  • K915654 — KERALLOY-D CAPS (March 2, 1992)
  • K912993 — WILDE DENTURE RESINS (February 3, 1992)

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)
  • 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)