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FDA 510(k)

TheraCal DC

K-Number: K180344 · 2018-04-05

ApplicantBisco, Inc.
Decision Date2018-04-05
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TheraCal DC is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K180344. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TheraCal DC?

TheraCal DC is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Bisco, Inc.. The 510(k) number is K180344.

When did TheraCal DC receive FDA 510(k) clearance?

TheraCal DC received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180344.

Who is the listed applicant for TheraCal DC?

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 TheraCal DC?

The FDA product code for TheraCal DC is EJK.

Other records listing Bisco, Inc. as applicant

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Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K253248Bright Cavity LinerDmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten 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.

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