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FDA 510(k)

FIBER OPTIC HANDPIECE

K-Number: K780483 · 1978-04-28

ApplicantSyntex Corp.
Decision Date1978-04-28
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBER OPTIC HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Corp.. It received FDA 510(k) clearance on 1978-04-28 under 510(k) number K780483. 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 FIBER OPTIC HANDPIECE?

FIBER OPTIC HANDPIECE is a medical device that received FDA 510(k) clearance on 1978-04-28. The listed applicant is Syntex Corp.. The 510(k) number is K780483.

When did FIBER OPTIC HANDPIECE receive FDA 510(k) clearance?

FIBER OPTIC HANDPIECE received FDA 510(k) clearance on 1978-04-28, under 510(k) number K780483.

Who is the listed applicant for FIBER OPTIC HANDPIECE?

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

What is the FDA product code for FIBER OPTIC HANDPIECE?

The FDA product code for FIBER OPTIC HANDPIECE is EFB.

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Other records listing Syntex Corp. 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.

K920314TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)K843593SURGIPRESS SURGICAL LOOPK780997AMALGAM ALLOYK780769S-100 CT SCANNERK761331OPUS I OPTION - FIBER OPTIC L SYSTEMK761332HI-SENSITIVITY MODE OPTION FOR S60-1A

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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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