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510(k) K020499

BOND-3 ADHESIVE by Jeneric/Pentron, Inc. — Product Code KLE

K020499 is an FDA 510(k) premarket notification submitted by Jeneric/Pentron, Inc. for the device "BOND-3 ADHESIVE". The FDA issued a decision of Substantially Equivalent on April 22, 2002. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Jeneric/Pentron, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2002
Date Received
February 14, 2002
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 Jeneric/Pentron, Inc.

  • K013543 — BOND-1 C & B (February 22, 2002)
  • K013542 — DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) (February 14, 2002)
  • K012231 — AVANTE MICRO CRYSTAL SYSTEM (August 23, 2001)
  • K011748 — FIRST FILL R.C.S. (August 3, 2001)
  • K010957 — QUELL DESENSITIZER (June 25, 2001)
  • K011331 — JP CAST 40 (June 22, 2001)
  • K011330 — JP CAST 50 (June 22, 2001)
  • K011362 — GOLD CORE 73 LS (May 29, 2001)
  • K010044 — COSMIC (February 9, 2001)
  • K003683 — AVANTE CURELIGHT (January 11, 2001)

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