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510(k) K230455

Device
Enamel Coating Resin
Applicant
Rizhao Huge Biomaterials Company, Ltd.
510(k) number
K230455
Product code
EBC
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-25
Date received
2023-02-21
Regulation
872.3765
Classification name
Sealant, Pit And Fissure, And Conditioner
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Maggie Zheng
Address
#2 N. Zhaoyang Rd., District Of Donggang Rizhao City CN 276800 276800

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260819Any-Com SealMediclus Co., Ltd.2026-05-01
K243254Parkell Pit and Fissure SealantParkell, Inc.2025-08-08
K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.2023-08-18
K190998BA Pit & Fissure SealantApex Dental Materials, Inc.2019-11-08
K190339Helioseal F PlusIvoclar Vivadent, AG2019-07-29
K172169Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation2018-01-05
K171330Nanova SealantNanova Biomaterials, Inc.2017-09-08
K162598HAPI SealBisco, Inc.2017-05-23
K161580Premier SealantPremier Dental Company Products2016-10-18
K141717PACSEAL PIT & FISSURE SEALANTPac-Dent International, Inc.2015-03-09
K130485CONTROL SEALVoco GmbH2014-02-11
K122521PREVENT SEALItena Clinical2013-06-11
K113818EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILLPulpdent Corporation2012-03-21
K112517ULTRASEAL XT HYDROUltradent Products, Inc.2011-09-23
K111782BEAUTISEALANTShofu Dental Corporation2011-09-16