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510(k) K101029

KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH by Huge Dental Material Co., Ltd. — Product Code ELM

K101029 is an FDA 510(k) premarket notification submitted by Huge Dental Material Co., Ltd. for the device "KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH". The FDA issued a decision of Substantially Equivalent on August 16, 2010. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Huge Dental Material Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2010
Date Received
April 13, 2010
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 Huge Dental Material Co., Ltd.

  • K201683 — PMMA Block (November 3, 2020)

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)
  • K093331 — SR PHONARES NHC (January 28, 2010)

FDA data resources