FDA 510(k)

3M VitCal Liner/Base

K-Number: K230270 · 2023-02-06

Decision Date2023-02-06

Product CodeEJK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

3M VitCal Liner/Base is a medical device manufactured by 3M Espe Dental Products. It received FDA 510(k) clearance on 2023-02-06 under approval 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. It is manufactured by 3M Espe Dental Products. The 510(k) number is K230270.

When was 3M VitCal Liner/Base approved by the FDA?

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

What company makes 3M VitCal Liner/Base?

3M VitCal Liner/Base is manufactured by 3M Espe Dental Products.

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

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

Other Devices by 3M Espe Dental Products

K1911223M RelyX Pediatric Resin Modified Glass Ionomer Cement K1834763M Filtek Universal Restorative K2313383M Clinpro Clear 2.1% Sodium Fluoride Treatment

Related Devices (Code: EJK)

K180344TheraCal DCBisco, Inc. K191103Parkell Desensitizer GelParkell, Inc. K202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH K201799CleaniCalMaruchi K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited K253248Bright Cavity LinerDmp Dental Industry S.A.

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.