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FDA 510(k)

UNI-FLEX RESIN

K-Number: K983461 · 1999-04-13

ApplicantTrans-Atlantic Dental
Decision Date1999-04-13
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNI-FLEX RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Trans-Atlantic Dental. It received FDA 510(k) clearance on 1999-04-13 under 510(k) number K983461. 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 UNI-FLEX RESIN?

UNI-FLEX RESIN is a medical device that received FDA 510(k) clearance on 1999-04-13. The listed applicant is Trans-Atlantic Dental. The 510(k) number is K983461.

When did UNI-FLEX RESIN receive FDA 510(k) clearance?

UNI-FLEX RESIN received FDA 510(k) clearance on 1999-04-13, under 510(k) number K983461.

Who is the listed applicant for UNI-FLEX RESIN?

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

What is the FDA product code for UNI-FLEX RESIN?

The FDA product code for UNI-FLEX RESIN is EBI.

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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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