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FDA 510(k)

DOLOTENS DENTAL TM 1

K-Number: K043373 · 2005-09-02

ApplicantNeuromuscular Technologies, Inc.
Decision Date2005-09-02
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DOLOTENS DENTAL TM 1 is the device name listed in this FDA 510(k) record. The listed applicant is Neuromuscular Technologies, Inc.. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K043373. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOLOTENS DENTAL TM 1?

DOLOTENS DENTAL TM 1 is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Neuromuscular Technologies, Inc.. The 510(k) number is K043373.

When did DOLOTENS DENTAL TM 1 receive FDA 510(k) clearance?

DOLOTENS DENTAL TM 1 received FDA 510(k) clearance on 2005-09-02, under 510(k) number K043373.

Who is the listed applicant for DOLOTENS DENTAL TM 1?

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

What is the FDA product code for DOLOTENS DENTAL TM 1?

The FDA product code for DOLOTENS DENTAL TM 1 is KZM.

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Related Devices (Code: KZM)

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.

K161716TEETHAN 2.0Bts S.P.A.K130158M-SCANBio-Research Associates, Inc.K113677GRINDCARE MEASUREMedotech A/SK082927BIOEMG IIIBio-Research Associates, Inc.K030869BITESTRIPS.L.P. , Ltd.K003176BIOEMG II AND BIOJVABio-Research Associates, Inc.

Official Source

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

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