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510(k) K030646

BELLEGLASS POINT 4 by Kerr Dental Materials Center — Product Code EBD

K030646 is an FDA 510(k) premarket notification submitted by Kerr Dental Materials Center for the device "BELLEGLASS POINT 4". The FDA issued a decision of Substantially Equivalent on May 6, 2003. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Kerr Dental Materials Center has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2003
Date Received
February 28, 2003
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 Kerr Dental Materials Center

  • K050984 — BIOPLANT (August 11, 2005)
  • K031444 — OPTIBOND FL (July 2, 2003)
  • K020303 — XR PRIMER 2 (April 19, 2002)
  • K020178 — BELLEGLASS HP MODELING GEL (March 15, 2002)
  • K014027 — OPTIBOND SOLO PLUS 4 (February 22, 2002)
  • K020092 — TEMPHASE (February 22, 2002)
  • K013375 — BELLEGLASS HP OPAQUE 2 (October 29, 2001)
  • K013325 — POINT 4 FLOWABLE 2 (October 23, 2001)
  • K011908 — OPTIBOND SOLO PLUS 3 (September 6, 2001)
  • K000357 — EZ CONNECT RESIN (April 28, 2000)

Other clearances for product code EBD

  • K254091 — GLOSSY COAT (15ML) (April 6, 2026)
  • 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)

FDA data resources