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FDA 510(k)

T1 LINE DENTAL HANDPIECES

K-Number: K972436 · 1997-09-22

ApplicantSiemens AG
Decision Date1997-09-22
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

T1 LINE DENTAL HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Siemens AG. It received FDA 510(k) clearance on 1997-09-22 under 510(k) number K972436. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T1 LINE DENTAL HANDPIECES?

T1 LINE DENTAL HANDPIECES is a medical device that received FDA 510(k) clearance on 1997-09-22. The listed applicant is Siemens AG. The 510(k) number is K972436.

When did T1 LINE DENTAL HANDPIECES receive FDA 510(k) clearance?

T1 LINE DENTAL HANDPIECES received FDA 510(k) clearance on 1997-09-22, under 510(k) number K972436.

Who is the listed applicant for T1 LINE DENTAL HANDPIECES?

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 LINE DENTAL HANDPIECES?

The FDA product code for T1 LINE DENTAL HANDPIECES is EFB.

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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: EFB)

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.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument 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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