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FDA 510(k)

MODIFICATION TO LINER II: SOFT RELINE LIQUID

K-Number: K991687 · 1999-10-07

ApplicantBosworth Co.
Decision Date1999-10-07
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LINER II: SOFT RELINE LIQUID is the device name listed in this FDA 510(k) record. The listed applicant is Bosworth Co.. It received FDA 510(k) clearance on 1999-10-07 under 510(k) number K991687. 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 MODIFICATION TO LINER II: SOFT RELINE LIQUID?

MODIFICATION TO LINER II: SOFT RELINE LIQUID is a medical device that received FDA 510(k) clearance on 1999-10-07. The listed applicant is Bosworth Co.. The 510(k) number is K991687.

When did MODIFICATION TO LINER II: SOFT RELINE LIQUID receive FDA 510(k) clearance?

MODIFICATION TO LINER II: SOFT RELINE LIQUID received FDA 510(k) clearance on 1999-10-07, under 510(k) number K991687.

Who is the listed applicant for MODIFICATION TO LINER II: SOFT RELINE LIQUID?

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 MODIFICATION TO LINER II: SOFT RELINE LIQUID?

The FDA product code for MODIFICATION TO LINER II: SOFT RELINE LIQUID 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.

K991902LC PIT & FISSURE SEALANTK953119BOSWORTH RESIN IIK810094DENTURE 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

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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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