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FDA 510(k)

TKO Composite Bite Turbo Gel

K-Number: K210349 · 2021-07-20

ApplicantReliance Orthodontic Products, Inc.
Decision Date2021-07-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TKO Composite Bite Turbo Gel is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2021-07-20 under 510(k) number K210349. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TKO Composite Bite Turbo Gel?

TKO Composite Bite Turbo Gel is a medical device that received FDA 510(k) clearance on 2021-07-20. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K210349.

When did TKO Composite Bite Turbo Gel receive FDA 510(k) clearance?

TKO Composite Bite Turbo Gel received FDA 510(k) clearance on 2021-07-20, under 510(k) number K210349.

Who is the listed applicant for TKO Composite Bite Turbo Gel?

The FDA 510(k) record lists Reliance Orthodontic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TKO Composite Bite Turbo Gel?

The FDA product code for TKO Composite Bite Turbo Gel is EBF.

Other records listing Reliance Orthodontic Products, Inc. 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.

K210945Ultra SEPK193388GlassLok Kits, GlassLok Powder, GlassLok LiquidK161684Quantum LB

Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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