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510(k) K010935

BRITESMILE BARRIER MATERIAL by Britesmile, Inc. — Product Code EIE

K010935 is an FDA 510(k) premarket notification submitted by Britesmile, Inc. for the device "BRITESMILE BARRIER MATERIAL". The FDA issued a decision of Substantially Equivalent on September 5, 2001. 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
September 5, 2001
Date Received
March 28, 2001
Clearance Type
Traditional
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.

  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)

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)
  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)
  • K022522 — PULPDENT PUTTY DAM (September 26, 2002)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 2002)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K983227 — POWER BLOCK (December 11, 1998)
  • K972775 — FASTDAM (February 27, 1998)

FDA data resources