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510(k) K040797

BRITESMILE MASKING CREAM by Britesmile, Inc. — Product Code EIE

K040797 is an FDA 510(k) premarket notification submitted by Britesmile, Inc. for the device "BRITESMILE MASKING CREAM". The FDA issued a decision of Substantially Equivalent on April 2, 2004. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Britesmile, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2004
Date Received
March 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

Other clearances by Britesmile, Inc.

  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)

Other clearances for product code EIE

  • K182118 — armor LC (May 3, 2019)
  • K151945 — Triumph Resin Dam (February 18, 2016)
  • K050318 — BARI-KAD PACKING DEVICE (March 4, 2005)
  • K043301 — GC TION GINGIVAL PROTECTOR (January 25, 2005)
  • K022522 — PULPDENT PUTTY DAM (September 26, 2002)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 2002)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K983227 — POWER BLOCK (December 11, 1998)
  • K972775 — FASTDAM (February 27, 1998)

FDA data resources