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FDA 510(k)

RDT3 HANDPIECE HEAD MODEL RDT3

K-Number: K101172 · 2010-07-27

ApplicantRedent Nova, Ltd.
Decision Date2010-07-27
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RDT3 HANDPIECE HEAD MODEL RDT3 is the device name listed in this FDA 510(k) record. The listed applicant is Redent Nova, Ltd.. It received FDA 510(k) clearance on 2010-07-27 under 510(k) number K101172. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RDT3 HANDPIECE HEAD MODEL RDT3?

RDT3 HANDPIECE HEAD MODEL RDT3 is a medical device that received FDA 510(k) clearance on 2010-07-27. The listed applicant is Redent Nova, Ltd.. The 510(k) number is K101172.

When did RDT3 HANDPIECE HEAD MODEL RDT3 receive FDA 510(k) clearance?

RDT3 HANDPIECE HEAD MODEL RDT3 received FDA 510(k) clearance on 2010-07-27, under 510(k) number K101172.

Who is the listed applicant for RDT3 HANDPIECE HEAD MODEL RDT3?

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

What is the FDA product code for RDT3 HANDPIECE HEAD MODEL RDT3?

The FDA product code for RDT3 HANDPIECE HEAD MODEL RDT3 is EFA.

Related Clinical Trials

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Other records listing Redent Nova, Ltd. as applicant

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.

K100606VATEA ENDONTIC IRRIGATION SYSTEMK092933SAF (SELF ADJUSTING FILE)

Related Devices (Code: EFA)

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.

K192809Dental HandpieceMicro-Nx Co., Ltd.K163239SMARTmaticKaltenbach & Voigt GmbHK093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEAnthogyrK092446INTRA LUX HEAD 3 LDSYKaltenbach & Voigt GmbH & Co.K090055LOW & HIGH SPEED KITDpm USA Corp.K092412STRONG IMPLANT HANDPIECESSaeshin Precision Co., Ltd.

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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