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FDA 510(k)

STRONG IMPLANT HANDPIECES

K-Number: K092412 · 2009-09-03

ApplicantSaeshin Precision Co., Ltd.
Decision Date2009-09-03
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRONG IMPLANT HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2009-09-03 under 510(k) number K092412. 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 STRONG IMPLANT HANDPIECES?

STRONG IMPLANT HANDPIECES is a medical device that received FDA 510(k) clearance on 2009-09-03. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K092412.

When did STRONG IMPLANT HANDPIECES receive FDA 510(k) clearance?

STRONG IMPLANT HANDPIECES received FDA 510(k) clearance on 2009-09-03, under 510(k) number K092412.

Who is the listed applicant for STRONG IMPLANT HANDPIECES?

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

What is the FDA product code for STRONG IMPLANT HANDPIECES?

The FDA product code for STRONG IMPLANT HANDPIECES is EFA.

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Other records listing Saeshin Precision Co., Ltd. as applicant

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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 GmbHK101172RDT3 HANDPIECE HEAD MODEL RDT3Redent Nova, Ltd.K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEAnthogyrK092446INTRA LUX HEAD 3 LDSYKaltenbach & Voigt GmbH & Co.K090055LOW & HIGH SPEED KITDpm USA Corp.

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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