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510(k) K896481

PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER by Purebrush Assoc. — Product Code MCF

K896481 is an FDA 510(k) premarket notification submitted by Purebrush Assoc. for the device "PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER". The FDA issued a decision of Substantially Equivalent on May 15, 1990. The device falls under product code MCF (Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile), a Class I device regulated under 21 CFR 872.6855.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1990
Date Received
November 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Device Class
Class I
Regulation Number
872.6855
Review Panel
DE
Submission Type

Other clearances for product code MCF

  • K023662 — PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER (May 28, 2003)
  • K021258 — GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER (May 10, 2002)
  • K003517 — OTRES TOOTHBRUSH SANITIZER MODEL TB100W (June 6, 2001)
  • K901459 — DS60 TOOTHBRUSH SANITIZER (September 17, 1990)

FDA data resources