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510(k) K041371

BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN by Novamin Technology, Inc. — Product Code EJR

K041371 is an FDA 510(k) premarket notification submitted by Novamin Technology, Inc. for the device "BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN". The FDA issued a decision of Substantially Equivalent on August 23, 2004. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Novamin Technology, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2004
Date Received
May 24, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Polishing, Abrasive, Oral Cavity
Device Class
Class I
Regulation Number
872.6030
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)
  • K040473 — ORAVIVE TOOTH REVITALIZING PASTE (March 10, 2004)
  • K033295 — BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN (October 28, 2003)

Other clearances for product code EJR

  • K171189 — AIR-FLOW PLUS Prophylaxis powder (September 11, 2017)
  • K131760 — WHIP MIX PREPPIES PLUS (March 26, 2014)
  • K121698 — NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN (August 6, 2012)
  • K103114 — OSSPRAY SYLC CR (March 14, 2011)
  • K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE (February 3, 2011)
  • K101104 — REMIN PRO (October 21, 2010)
  • K100539 — PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (June 17, 2010)
  • K070854 — GC MI PASTE PLUS (April 12, 2007)
  • K062502 — OSSPRAY CLEANING COMPOUND (December 15, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)

FDA data resources