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FDA 510(k)

ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP

K-Number: K093084 · 2009-12-16

ApplicantRolence Ent., Inc.
Decision Date2009-12-16
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP is the device name listed in this FDA 510(k) record. The listed applicant is Rolence Ent., Inc.. It received FDA 510(k) clearance on 2009-12-16 under 510(k) number K093084. 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 ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP?

ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP is a medical device that received FDA 510(k) clearance on 2009-12-16. The listed applicant is Rolence Ent., Inc.. The 510(k) number is K093084.

When did ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP receive FDA 510(k) clearance?

ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP received FDA 510(k) clearance on 2009-12-16, under 510(k) number K093084.

Who is the listed applicant for ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP?

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

What is the FDA product code for ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP?

The FDA product code for ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP 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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