FDA 510(k)

TheraCem

K-Number: K161256 · 2016-07-29

Decision Date2016-07-29

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TheraCem is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161256. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TheraCem?

TheraCem is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Bisco, Inc.. The 510(k) number is K161256.

When did TheraCem receive FDA 510(k) clearance?

TheraCem received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161256.

Who is the listed applicant for TheraCem?

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

What is the FDA product code for TheraCem?

The FDA product code for TheraCem is EMA.

Other records listing Bisco, 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.

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Related Devices (Code: EMA)

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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.