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510(k) K033295

BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN by Novamin Technology, Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2003
Date Received
October 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

  • K080228 — ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH (March 27, 2008)
  • 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)

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  • K242913 — Jasmate® Toothpaste (November 22, 2024)
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  • K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal (July 24, 2023)
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