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FDA 510(k)

CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP

K-Number: K881985 · 1988-07-25

ApplicantDenticator
Decision Date1988-07-25
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP is the device name listed in this FDA 510(k) record. The listed applicant is Denticator. It received FDA 510(k) clearance on 1988-07-25 under 510(k) number K881985. 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 CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP?

CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP is a medical device that received FDA 510(k) clearance on 1988-07-25. The listed applicant is Denticator. The 510(k) number is K881985.

When did CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP receive FDA 510(k) clearance?

CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP received FDA 510(k) clearance on 1988-07-25, under 510(k) number K881985.

Who is the listed applicant for CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP?

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

What is the FDA product code for CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP?

The FDA product code for CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP is EFB.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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