FDA.reportPublic FDA data

Ceramic Coupling Agent

Primary DI
06972220484325
Brand
Ceramic Coupling Agent
Company
Rizhao HuGe Biomaterials Company, Ltd.
Model
5ml
Published
2024-12-09
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242749000TopCEM Ceramic Primer Ceramic Coupling AgentRizhao Huge Biomaterials Company, Ltd.2024-11-08KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972220484325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972220484325069722204843256972220484325

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis priming agentA material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544452689
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970006745660Light Cure Dental Adhesive/6ml2026-10-25
06970006745677Universal Composite Restorative/A2/4g/TrusFIL X-Blend2026-10-25
06970006746568Phosphoric Acid Etching GelE371ml*12026-10-25
06970006746575TrusFIL-Flow Flowable Composite Restorative/DO/2g2026-10-25
06970006746582TrusFIL-Flow Flowable Composite Restorative/PR/2g2026-10-25
06970006746599TrusFIL-Flow Flowable Composite Restorative/Br/2g2026-10-25
06970006746605TrusFIL-Flow Flowable Composite Restorative/DR/2g2026-10-25
06970006746612TrusFIL-Flow Flowable Composite Restorative/LR/2g2026-10-25
06970006746629TrusFIL-Flow Flowable Composite Restorative/P1/2g2026-10-25
06970006746636TrusFIL-Flow Flowable Composite Restorative/P2/2g2026-10-25
06970006746643TrusFIL-Flow Flowable Composite Restorative/P3/2g2026-10-25
06970006746650TrusFIL-Flow Flowable Composite Restorative/YP/2g2026-10-25
06970006746667TrusFIL-Flow Flowable Composite Restorative/DP/2g2026-10-25
06970006746674TrusFIL-Flow Flowable Composite Restorative/LT/2g2026-10-25
06970006746681TrusFIL-Flow Flowable Composite Restorative/WO/2g2026-10-25
06970006746698TrusFIL-Flow Flowable Composite Restorative/WT/2g2026-10-25
06970006746704Universal Composite Restorative/DO/4g2026-10-25
06970006746711Universal Composite Restorative/PR/4g2026-10-25
06970006746728Universal Composite Restorative/DR/4g2026-10-25
06970006746735Universal Composite Restorative/LR/4g2026-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970006745660Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06970006746568Phosphoric Acid Etching GelRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06972220488958Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
00197998079917Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079955Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079962Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079986Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079993Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998080005Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998099984Solventum™ RelyX™Solventum Germany GmbHEMA2026-10-08
00197998226724Solventum™ Protemp™Solventum Germany GmbHEMA2026-10-08
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
00840456224366JMUJMU DENTAL, INCKLE2026-07-22
00840456224441JMUJMU DENTAL, INCKLE2026-07-22
07615208570830Adhese 2 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-07-22
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04