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FDA 510(k)

C&B Ceramic; C&B Permanent; C&B Interim

K-Number: K233273 · 2024-11-27

ApplicantPrevest Denpro Limited
Decision Date2024-11-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

C&B Ceramic; C&B Permanent; C&B Interim is the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K233273. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C&B Ceramic; C&B Permanent; C&B Interim?

C&B Ceramic; C&B Permanent; C&B Interim is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Prevest Denpro Limited. The 510(k) number is K233273.

When did C&B Ceramic; C&B Permanent; C&B Interim receive FDA 510(k) clearance?

C&B Ceramic; C&B Permanent; C&B Interim received FDA 510(k) clearance on 2024-11-27, under 510(k) number K233273.

Who is the listed applicant for C&B Ceramic; C&B Permanent; C&B Interim?

The FDA 510(k) record lists Prevest Denpro Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C&B Ceramic; C&B Permanent; C&B Interim?

The FDA product code for C&B Ceramic; C&B Permanent; C&B Interim is EBF.

Other records listing Prevest Denpro Limited 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.

K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTK231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalK213244Accusil 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/LiquidK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

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Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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