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FDA 510(k)

ATR 3000, ATR 2000, IMPLANT-PRO

K-Number: K991401 · 1999-12-15

ApplicantAdvanced Technology Research (A.T.R.) S.R.P.
Decision Date1999-12-15
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATR 3000, ATR 2000, IMPLANT-PRO is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Research (A.T.R.) S.R.P.. It received FDA 510(k) clearance on 1999-12-15 under 510(k) number K991401. 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 ATR 3000, ATR 2000, IMPLANT-PRO?

ATR 3000, ATR 2000, IMPLANT-PRO is a medical device that received FDA 510(k) clearance on 1999-12-15. The listed applicant is Advanced Technology Research (A.T.R.) S.R.P.. The 510(k) number is K991401.

When did ATR 3000, ATR 2000, IMPLANT-PRO receive FDA 510(k) clearance?

ATR 3000, ATR 2000, IMPLANT-PRO received FDA 510(k) clearance on 1999-12-15, under 510(k) number K991401.

Who is the listed applicant for ATR 3000, ATR 2000, IMPLANT-PRO?

The FDA 510(k) record lists Advanced Technology Research (A.T.R.) S.R.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATR 3000, ATR 2000, IMPLANT-PRO?

The FDA product code for ATR 3000, ATR 2000, IMPLANT-PRO is EFB.

Related Clinical Trials

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.

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Other records listing Advanced Technology Research (A.T.R.) S.R.P. 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.

K000547ATR TECNIKA

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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