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510(k) K042806

QUADRANT UNIT-1-BOND by Cavex Holland BV — Product Code KLE

K042806 is an FDA 510(k) premarket notification submitted by Cavex Holland BV for the device "QUADRANT UNIT-1-BOND". The FDA issued a decision of Substantially Equivalent on November 24, 2004. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Cavex Holland BV has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2004
Date Received
October 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Cavex Holland BV

  • K151535 — Cavex Cream Alginate (October 28, 2015)
  • K141092 — MARK3 (December 4, 2014)
  • K073539 — PROVISA CEM (January 31, 2008)
  • K072245 — EMULATE ADVANCED (November 8, 2007)
  • K062400 — IMPRESSIX, COLORCHANGE ALGINATE (November 16, 2006)
  • K061267 — SIMULATE, COLOR CHANGE ALGINATE (July 10, 2006)
  • K052455 — IMPRESSIX (November 23, 2005)
  • K051207 — CAVEX ORTHOTRACE (June 21, 2005)
  • K032116 — TULIP COLORSWITCH (September 30, 2003)
  • K023466 — TULIP ALGINATE IMPRESSION MATERIAL (December 13, 2002)

Other clearances for product code KLE

  • K260485 — Any-Etch (May 14, 2026)
  • K260430 — Porcelain Etch Gel (April 10, 2026)
  • K252450 — Adhese 2 (March 5, 2026)
  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K251587 — VITA VMLC Primer (February 23, 2026)
  • K252151 — els unibond (December 5, 2025)
  • K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (November 6, 2025)
  • K251124 — G-Bond Universal (October 2, 2025)
  • K242530 — HF-Etchant Hydrofluoric Acid Etching Gel (December 20, 2024)
  • K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent (November 8, 2024)

FDA data resources