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FDA 510(k)

T1 CONTROL HIGH SPEED DENTAL HANDPIECE

K-Number: K965238 · 1997-03-19

ApplicantSiemens AG
Decision Date1997-03-19
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

T1 CONTROL HIGH SPEED DENTAL HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens AG. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K965238. 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 T1 CONTROL HIGH SPEED DENTAL HANDPIECE?

T1 CONTROL HIGH SPEED DENTAL HANDPIECE is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Siemens AG. The 510(k) number is K965238.

When did T1 CONTROL HIGH SPEED DENTAL HANDPIECE receive FDA 510(k) clearance?

T1 CONTROL HIGH SPEED DENTAL HANDPIECE received FDA 510(k) clearance on 1997-03-19, under 510(k) number K965238.

Who is the listed applicant for T1 CONTROL HIGH SPEED DENTAL HANDPIECE?

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

What is the FDA product code for T1 CONTROL HIGH SPEED DENTAL HANDPIECE?

The FDA product code for T1 CONTROL HIGH SPEED DENTAL HANDPIECE is EFA.

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Other records listing Siemens AG 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.

K123375SYNGO.VIAK110366SYNGO.CT CARDIAC FUNCTIONK071310SYNGO CT ONCOLOGY SOFTWARE PACKAGEK063507SYNGO NEURO PBV CTK063373FLEX LOOP COIL SET 3TK053024SYNGO NEURO DSA CT

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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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