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FDA 510(k)

PRO-FLEX DISPOSABLE PROPHY ANGLE

K-Number: K981869 · 1998-08-11

ApplicantProfessional Dental Mfg., Inc.
Decision Date1998-08-11
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRO-FLEX DISPOSABLE PROPHY ANGLE is the device name listed in this FDA 510(k) record. The listed applicant is Professional Dental Mfg., Inc.. It received FDA 510(k) clearance on 1998-08-11 under 510(k) number K981869. 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 PRO-FLEX DISPOSABLE PROPHY ANGLE?

PRO-FLEX DISPOSABLE PROPHY ANGLE is a medical device that received FDA 510(k) clearance on 1998-08-11. The listed applicant is Professional Dental Mfg., Inc.. The 510(k) number is K981869.

When did PRO-FLEX DISPOSABLE PROPHY ANGLE receive FDA 510(k) clearance?

PRO-FLEX DISPOSABLE PROPHY ANGLE received FDA 510(k) clearance on 1998-08-11, under 510(k) number K981869.

Who is the listed applicant for PRO-FLEX DISPOSABLE PROPHY ANGLE?

The FDA 510(k) record lists Professional Dental Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-FLEX DISPOSABLE PROPHY ANGLE?

The FDA product code for PRO-FLEX DISPOSABLE PROPHY ANGLE is EFB.

Related Clinical Trials

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Other records listing Professional Dental Mfg., Inc. 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.

K964596PROSELECT 3 PERIDONTAL THERAPY SYSTEM

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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