Home / 510(k) Clearances / K980298

510(k) K980298

FLOWABLE HYBRID by Cosmedent, Inc. — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1998
Date Received
January 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
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)
  • K060881 — TEMPORARY CROWN & BRIDGE RESIN (May 16, 2006)
  • K052263 — MULTIPLE (TOOTH DESENSITIZER) (December 16, 2005)
  • K052501 — MULTIPLE RESIN TOOTH BONDING AGENT (October 21, 2005)

Other clearances for product code EBD

  • K250804 — ID LIGHT CURE SYSTEM (June 4, 2025)
  • K240735 — visio.lign color, visio.lign shield (December 12, 2024)
  • K223365 — RODIN Palette Naturalizing Kit (March 27, 2023)
  • K211854 — VITA Akzent LC (November 22, 2021)
  • K162408 — Nano Varnish, Plaquit, Lightpaint on Surface (April 5, 2018)
  • K163568 — SHOFU RESIN GLAZE (August 16, 2017)
  • K133836 — OPTIGLAZE COLOR (March 6, 2014)
  • K123761 — VITA ENAMIC STAINS (March 1, 2013)
  • K093019 — ENAMELITE ACRYSEAL SPRAY SEALANT (December 22, 2009)
  • K082285 — EASY GLAZE (October 24, 2008)