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FDA 510(k)

OptiComp

K-Number: K202920 · 2022-05-25

ApplicantPac-Dent, Inc.
Decision Date2022-05-25
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OptiComp is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K202920. 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 OptiComp?

OptiComp is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K202920.

When did OptiComp receive FDA 510(k) clearance?

OptiComp received FDA 510(k) clearance on 2022-05-25, under 510(k) number K202920.

Who is the listed applicant for OptiComp?

The FDA 510(k) record lists Pac-Dent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiComp?

The FDA product code for OptiComp is EBF.

Other records listing Pac-Dent, Inc. as applicant

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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

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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