Home / 510(k) Clearances / K060881

510(k) K060881

TEMPORARY CROWN & BRIDGE RESIN by Cosmedent, Inc. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2006
Date Received
March 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

Other clearances by Cosmedent, Inc.

  • K240714 — Insure® Universal; Insure® Universal Automix (July 24, 2024)
  • K222435 — Renamel® Microhybrid ;Renamel® Flowable Microhybrid (October 11, 2022)
  • K211259 — Renamel Bulkfill (June 24, 2021)
  • K172707 — Renamel Microfill (December 5, 2017)
  • K163480 — Renamel NANO +plus (February 24, 2017)
  • K092730 — COSMEDENT BRUSHABLE COMPOSITE (November 20, 2009)
  • K070583 — NANO COMPOSITE (April 16, 2007)
  • K052263 — MULTIPLE (TOOTH DESENSITIZER) (December 16, 2005)
  • K052501 — MULTIPLE RESIN TOOTH BONDING AGENT (October 21, 2005)
  • K042823 — COSMEDENT PIT & FISSURE SEALANT (December 1, 2004)

Other clearances for product code EBG

  • K253380 — “FLNT Base” and “FLNT Temp” (March 2, 2026)
  • K251271 — TempFIT Temporary Crown and Bridge Resin (June 23, 2025)
  • K243370 — DentaTOOTH (May 5, 2025)
  • K243621 — Evoblock, Perléon (April 22, 2025)
  • K243951 — TEMP MASTER, PMMA-based dental resin (February 21, 2025)
  • K231859 — PrimmaArt (November 26, 2024)
  • K242559 — Digital Temp (November 26, 2024)
  • K240538 — Premium Teeth Resin (July 19, 2024)
  • K241226 — Fixtemp® C&B 4:1 (May 31, 2024)
  • K233868 — dima Print Teeth & Temp (May 23, 2024)