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FDA 510(k)

ALIGN SYSTEM

K-Number: K981095 · 1998-09-08

ApplicantAlign Technology
Decision Date1998-09-08
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALIGN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology. It received FDA 510(k) clearance on 1998-09-08 under 510(k) number K981095. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALIGN SYSTEM?

ALIGN SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Align Technology. The 510(k) number is K981095.

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

ALIGN SYSTEM received FDA 510(k) clearance on 1998-09-08, under 510(k) number K981095.

Who is the listed applicant for ALIGN SYSTEM?

The FDA 510(k) record lists Align Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALIGN SYSTEM?

The FDA product code for ALIGN SYSTEM is NXC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Align Technology 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.

K081960INVISALIGN SYSTEM

Related Devices (Code: NXC)

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.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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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