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FDA 510(k)

ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES

K-Number: K072554 · 2007-11-14

ApplicantSable Industries, Inc.
Decision Date2007-11-14
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Sable Industries, Inc.. It received FDA 510(k) clearance on 2007-11-14 under 510(k) number K072554. 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 ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES?

ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES is a medical device that received FDA 510(k) clearance on 2007-11-14. The listed applicant is Sable Industries, Inc.. The 510(k) number is K072554.

When did ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES receive FDA 510(k) clearance?

ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES received FDA 510(k) clearance on 2007-11-14, under 510(k) number K072554.

Who is the listed applicant for ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES?

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

What is the FDA product code for ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES?

The FDA product code for ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES is EFB.

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Other records listing Sable Industries, 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.

K083101PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES

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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