Decision Date2024-11-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
C&B Ceramic; C&B Permanent; C&B Interim is a medical device manufactured by Prevest Denpro Limited. It received FDA 510(k) clearance on 2024-11-27 under approval 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. It is manufactured by Prevest Denpro Limited. The 510(k) number is K233273.
When was C&B Ceramic; C&B Permanent; C&B Interim approved by the FDA?
C&B Ceramic; C&B Permanent; C&B Interim received FDA 510(k) clearance on 2024-11-27, under approval number K233273.
What company makes C&B Ceramic; C&B Permanent; C&B Interim?
C&B Ceramic; C&B Permanent; C&B Interim is manufactured by Prevest Denpro Limited.
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 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
K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
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Related Devices (Code: EBF)
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.