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510(k) K003517

OTRES TOOTHBRUSH SANITIZER MODEL TB100W by Otres, LLC — Product Code MCF

K003517 is an FDA 510(k) premarket notification submitted by Otres, LLC for the device "OTRES TOOTHBRUSH SANITIZER MODEL TB100W". The FDA issued a decision of Substantially Equivalent on June 6, 2001. 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
June 6, 2001
Date Received
November 14, 2000
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)
  • K901459 — DS60 TOOTHBRUSH SANITIZER (September 17, 1990)
  • K896481 — PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER (May 15, 1990)

FDA data resources