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FDA 510(k)

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

K-Number: K212475 · 2022-05-13

ApplicantPrevest Denpro Limited
Decision Date2022-05-13
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is a medical device manufactured by Prevest Denpro Limited. It received FDA 510(k) clearance on 2022-05-13 under approval number K212475. 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 Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Prevest Denpro Limited. The 510(k) number is K212475.

When was Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) approved by the FDA?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) received FDA 510(k) clearance on 2022-05-13, under approval number K212475.

What company makes Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is manufactured by Prevest Denpro Limited.

What is the FDA product code for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

The FDA product code for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is EJK.

Other Devices by Prevest Denpro Limited

K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal K233273C&B Ceramic; C&B Permanent; C&B Interim K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

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Related Devices (Code: EJK)

K180344TheraCal DCBisco, Inc. K191103Parkell Desensitizer GelParkell, Inc. K202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH K201799CleaniCalMaruchi K2302703M™ VitCal Liner/Base3M Espe Dental Products K253248Bright Cavity LinerDmp Dental Industry S.A.

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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