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FDA 510(k)

BOSWORTH RESIN II

K-Number: K953119 · 1995-08-28

ApplicantBosworth Co.
Decision Date1995-08-28
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BOSWORTH RESIN II is the device name listed in this FDA 510(k) record. The listed applicant is Bosworth Co.. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K953119. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSWORTH RESIN II?

BOSWORTH RESIN II is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Bosworth Co.. The 510(k) number is K953119.

When did BOSWORTH RESIN II receive FDA 510(k) clearance?

BOSWORTH RESIN II received FDA 510(k) clearance on 1995-08-28, under 510(k) number K953119.

Who is the listed applicant for BOSWORTH RESIN II?

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

What is the FDA product code for BOSWORTH RESIN II?

The FDA product code for BOSWORTH RESIN II is EBI.

Related Clinical Trials

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Other records listing 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.

K991687MODIFICATION TO LINER II: SOFT RELINE LIQUIDK991902LC PIT & FISSURE SEALANTK810094DENTURE RUBBER BASE MATERIAL

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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