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510(k) K092231

GEBDI TRIBOS 501 by Gebdi Dental-Products GmbH — Product Code ELM

K092231 is an FDA 510(k) premarket notification submitted by Gebdi Dental-Products GmbH for the device "GEBDI TRIBOS 501". The FDA issued a decision of Substantially Equivalent on November 24, 2009. 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
November 24, 2009
Date Received
July 23, 2009
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 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