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510(k) K080228

ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH by Novamin Technology, Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2008
Date Received
January 30, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

Other clearances by Novamin Technology, Inc.

  • K071267 — PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN (May 18, 2007)
  • K061359 — DENSHIELD TREATMENT FOR SENSITIVE TEETH (October 18, 2006)
  • K040858 — ORALIEF THERAPY FOR SENSITIVE TEETH (September 2, 2004)
  • K041371 — BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN (August 23, 2004)
  • K040473 — ORAVIVE TOOTH REVITALIZING PASTE (March 10, 2004)
  • K033295 — BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN (October 28, 2003)

Other clearances for product code LBH

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  • K241489 — ReminGel (January 8, 2025)
  • K241568 — CrystLCare™ PRO Biorestorative, Fluoride-Plus (January 2, 2025)
  • K242913 — Jasmate® Toothpaste (November 22, 2024)
  • K233768 — Papacarie Duo (July 18, 2024)
  • K231060 — ProMin Dental Desensitizing Gel (June 13, 2024)
  • K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal (July 24, 2023)
  • K222891 — Dental Desensitizer (May 25, 2023)
  • K231338 — 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment (May 10, 2023)