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FDA 510(k)

OTRES TOOTHBRUSH SANITIZER MODEL TB100W

K-Number: K003517 · 2001-06-06

ApplicantOtres, LLC
Decision Date2001-06-06
Product CodeMCF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OTRES TOOTHBRUSH SANITIZER MODEL TB100W is the device name listed in this FDA 510(k) record. The listed applicant is Otres, LLC. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K003517. The device is classified under product code MCF. It was reviewed by the DE advisory panel. Product code MCF falls under the category of Surgical Instruments, which includes handheld instruments for general and specialized surgical procedures. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTRES TOOTHBRUSH SANITIZER MODEL TB100W?

OTRES TOOTHBRUSH SANITIZER MODEL TB100W is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Otres, LLC. The 510(k) number is K003517.

When did OTRES TOOTHBRUSH SANITIZER MODEL TB100W receive FDA 510(k) clearance?

OTRES TOOTHBRUSH SANITIZER MODEL TB100W received FDA 510(k) clearance on 2001-06-06, under 510(k) number K003517.

Who is the listed applicant for OTRES TOOTHBRUSH SANITIZER MODEL TB100W?

The FDA 510(k) record lists Otres, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTRES TOOTHBRUSH SANITIZER MODEL TB100W?

The FDA product code for OTRES TOOTHBRUSH SANITIZER MODEL TB100W is MCF. This falls under the Surgical Instruments category.

Related Clinical Trials

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Related Devices (Code: MCF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023662PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZERHwadong International Company , Ltd.K021258GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZERGerm Terminator CorporationK901459DS60 TOOTHBRUSH SANITIZERAssociated Mills, Inc.K896481PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZERPurebrush Assoc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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