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FDA 510(k)

AXIS SYSTEM

K-Number: K072989 · 2008-01-28

ApplicantDentsply Intl., Inc.
Decision Date2008-01-28
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AXIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl., Inc.. It received FDA 510(k) clearance on 2008-01-28 under 510(k) number K072989. 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 AXIS SYSTEM?

AXIS SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-28. The listed applicant is Dentsply Intl., Inc.. The 510(k) number is K072989.

When did AXIS SYSTEM receive FDA 510(k) clearance?

AXIS SYSTEM received FDA 510(k) clearance on 2008-01-28, under 510(k) number K072989.

Who is the listed applicant for AXIS SYSTEM?

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

What is the FDA product code for AXIS SYSTEM?

The FDA product code for AXIS SYSTEM is EFB.

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Other records listing Dentsply Intl., Inc. as applicant

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K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEMK103244QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTIONK093221PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION IIK083805ANKYLOS C/X DENTAL IMPLANT SYSTEMK082198DURASHIELD PLUSK073117DENTIN DESENSITIZER AGENT

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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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