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FDA 510(k)

PROPHYFLEX 2, MODEL 2012

K-Number: K973876 · 1997-12-19

ApplicantKavo America
Decision Date1997-12-19
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPHYFLEX 2, MODEL 2012 is the device name listed in this FDA 510(k) record. The listed applicant is Kavo America. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K973876. 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 PROPHYFLEX 2, MODEL 2012?

PROPHYFLEX 2, MODEL 2012 is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Kavo America. The 510(k) number is K973876.

When did PROPHYFLEX 2, MODEL 2012 receive FDA 510(k) clearance?

PROPHYFLEX 2, MODEL 2012 received FDA 510(k) clearance on 1997-12-19, under 510(k) number K973876.

Who is the listed applicant for PROPHYFLEX 2, MODEL 2012?

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

What is the FDA product code for PROPHYFLEX 2, MODEL 2012?

The FDA product code for PROPHYFLEX 2, MODEL 2012 is EFB.

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Other records listing Kavo America 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.

K073074KEY LASER III 1243 US WITH DETECTK072262GENTLERAY 980 DIODE LASER SYSTEMK063624KAVO EVEREST C-TEMPK051909DIAGNODENTK030146KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+K050019IN EXAM INTRAORAL DENTAL X-RAY SYSTEM

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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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