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FDA 510(k)

ACTA

K-Number: K961735 · 1996-07-31

ApplicantSatelec
Decision Date1996-07-31
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACTA is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 1996-07-31 under 510(k) number K961735. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTA?

ACTA is a medical device that received FDA 510(k) clearance on 1996-07-31. The listed applicant is Satelec. The 510(k) number is K961735.

When did ACTA receive FDA 510(k) clearance?

ACTA received FDA 510(k) clearance on 1996-07-31, under 510(k) number K961735.

Who is the listed applicant for ACTA?

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

What is the FDA product code for ACTA?

The FDA product code for ACTA is EBZ.

Related PubMed Literature

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.

PMID: 31116763Identifying extractable profiles from 3D printed medical devices.PloS one ()

Other records listing Satelec 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.

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Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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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