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FDA 510(k)

3M™ VitCal Liner/Base

K-Number: K230270 · 2023-02-06

Applicant3M Espe Dental Products
Decision Date2023-02-06
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M™ VitCal Liner/Base is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2023-02-06 under 510(k) number K230270. 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 3M™ VitCal Liner/Base?

3M™ VitCal Liner/Base is a medical device that received FDA 510(k) clearance on 2023-02-06. The listed applicant is 3M Espe Dental Products. The 510(k) number is K230270.

When did 3M™ VitCal Liner/Base receive FDA 510(k) clearance?

3M™ VitCal Liner/Base received FDA 510(k) clearance on 2023-02-06, under 510(k) number K230270.

Who is the listed applicant for 3M™ VitCal Liner/Base?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ VitCal Liner/Base?

The FDA product code for 3M™ VitCal Liner/Base is EJK.

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.

NCT07261137Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental RestorationsTERMINATED

Other records listing 3M Espe Dental Products 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.

K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentK1911223M RelyX Pediatric Resin Modified Glass Ionomer CementK1834763M Filtek Universal Restorative

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.K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbHK191103Parkell Desensitizer GelParkell, 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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