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510(k) K771398

SHELL VENEER by L.D. Caulk Co. — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1977
Date Received
July 29, 1977
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 L.D. Caulk Co.

  • K802262 — COMPOSITE RESTORATIVE (September 16, 1980)
  • K801690 — VALIANT (August 13, 1980)
  • K790585 — FINESSE (May 16, 1979)
  • K790586 — CHEMBOND (May 16, 1979)
  • K780560 — DENTAL AMALGAMATOR (April 21, 1978)
  • K780384 — IMPROVED DYCAL (March 15, 1978)
  • K780301 — CAULK TYLOK (February 28, 1978)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K771402 — NUVA-COTE (MODIFICATION TO) (August 26, 1977)
  • K771403 — EASE (MODIFICATION TO) (August 22, 1977)

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)