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FDA 510(k)

BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP

K-Number: K103585 · 2011-03-04

ApplicantHarry J. Bosworth Co.
Decision Date2011-03-04
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP is the device name listed in this FDA 510(k) record. The listed applicant is Harry J. Bosworth Co.. It received FDA 510(k) clearance on 2011-03-04 under 510(k) number K103585. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP?

BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP is a medical device that received FDA 510(k) clearance on 2011-03-04. The listed applicant is Harry J. Bosworth Co.. The 510(k) number is K103585.

When did BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP receive FDA 510(k) clearance?

BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP received FDA 510(k) clearance on 2011-03-04, under 510(k) number K103585.

Who is the listed applicant for BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP?

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

What is the FDA product code for BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP?

The FDA product code for BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP is EMA.

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Other records listing Harry J. Bosworth Co. 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.

K100731BOSWORTH AIR POLISHERK061611BOSWORTH DENTIN RESINK051224BOSWORTH SEALK043170BOSWORTH BONDK040548AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVEK040547AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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