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FDA 510(k)

TUF LINK SILICONE RELINER

K-Number: K042931 · 2004-12-08

ApplicantDentatus USA , Ltd.
Decision Date2004-12-08
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TUF LINK SILICONE RELINER is the device name listed in this FDA 510(k) record. The listed applicant is Dentatus USA , Ltd.. It received FDA 510(k) clearance on 2004-12-08 under 510(k) number K042931. 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 TUF LINK SILICONE RELINER?

TUF LINK SILICONE RELINER is a medical device that received FDA 510(k) clearance on 2004-12-08. The listed applicant is Dentatus USA , Ltd.. The 510(k) number is K042931.

When did TUF LINK SILICONE RELINER receive FDA 510(k) clearance?

TUF LINK SILICONE RELINER received FDA 510(k) clearance on 2004-12-08, under 510(k) number K042931.

Who is the listed applicant for TUF LINK SILICONE RELINER?

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

What is the FDA product code for TUF LINK SILICONE RELINER?

The FDA product code for TUF LINK SILICONE RELINER is EBI.

Related Clinical Trials

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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Other records listing Dentatus USA , Ltd. 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.

K031793DENTATUS OSCIOMATK980620DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEMK961704MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM

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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