Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pac-Dent Ceramic Nanohybrid Resin

K-Number: K210412 · 2021-07-26

ApplicantPac-Dent, Inc.
Decision Date2021-07-26
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pac-Dent Ceramic Nanohybrid Resin is a medical device manufactured by Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-07-26 under approval number K210412. 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 Pac-Dent Ceramic Nanohybrid Resin?

Pac-Dent Ceramic Nanohybrid Resin is a medical device that received FDA 510(k) clearance on 2021-07-26. It is manufactured by Pac-Dent, Inc.. The 510(k) number is K210412.

When was Pac-Dent Ceramic Nanohybrid Resin approved by the FDA?

Pac-Dent Ceramic Nanohybrid Resin received FDA 510(k) clearance on 2021-07-26, under approval number K210412.

What company makes Pac-Dent Ceramic Nanohybrid Resin?

Pac-Dent Ceramic Nanohybrid Resin is manufactured by Pac-Dent, Inc..

What is the FDA product code for Pac-Dent Ceramic Nanohybrid Resin?

The FDA product code for Pac-Dent Ceramic Nanohybrid Resin is EBF.

Related Clinical Trials

NCT07524842 Clinical Performance of Three Different Restorative Materials NOT_YET_RECRUITING NCT03716817 TetricCAD Crown Clinical Study COMPLETED NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Other Devices by Pac-Dent, Inc.

K200330RC-Prime Root Canal Preparation Cream K202831The iMask Child's Face Mask K210189Pac-Dent Denture Base Resin K210186PacBond One K201182iMask Disposable Surgical Face Mask K202674Medidenta High Speed Handpieces

View all 8 devices →

Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

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.

↑