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510(k) K810970

ISOSIT TEETH by Bauer, Cheng & Associates, Inc. — Product Code ELM

K810970 is an FDA 510(k) premarket notification submitted by Bauer, Cheng & Associates, Inc. for the device "ISOSIT TEETH". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Bauer, Cheng & Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
April 9, 1981
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 Bauer, Cheng & Associates, Inc.

  • K840084 — COLTENE BRILLIANT LUX (March 30, 1984)
  • K840085 — COLTENE BRILLIANT (March 16, 1984)
  • K823097 — NATURELLE (November 10, 1982)
  • K823084 — CHALLENGER (November 10, 1982)
  • K823098 — REX-CAPS (November 10, 1982)
  • K823099 — RX MIDACAST (November 10, 1982)
  • K823100 — RX 91 (November 10, 1982)
  • K810971 — THE GNATOMET (May 5, 1981)
  • K810972 — THE GNATHOMETER-M (May 5, 1981)
  • K810969 — ISOSIT C & B MATERIAL (May 5, 1981)

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)

FDA data resources