FDA.reportPublic FDA data

Light Cure Dental Adhesive

Primary DI
06972220484301
Brand
Light Cure Dental Adhesive
Company
Rizhao HuGe Biomaterials Company, Ltd.
Model
/
Catalog number
5ml
Published
2021-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201787000Light Cure Dental AdhesiveRizhao Huge Biomaterials Company, Ltd.2020-09-25KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972220484301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972220484301069722204843016972220484301

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. 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
06970006744069TopCEM Dual Cure Resin CementAutomixA0/8g/A*10,B2*5/UltraCore2026-04-22
06970006744076TopCEM Dual Cure Resin CementAutomixA1/8g/A*10,B2*5/UltraCore2026-04-22
06970006744083TopCEM Dual Cure Resin CementAutomixA2/8g/A*10,B2*5/UltraCore2026-04-22
06970006744090TopCEM Dual Cure Resin CementAutomixA3/8g/A*10,B2*5/UltraCore2026-04-22
06970006744106TopCEM Dual Cure Resin CementAutomixTR/8g/A*10,B2*5/UltraCore2026-04-22
06970006744113TopCEM Dual Cure Resin CementAutomixOpaque/8g/A*10,B2*5/UltraCore2026-04-22
06970006744120TopCEM Dual Cure Resin CementAutomixWhite/8g/A*10,B2*5/UltraCore2026-04-22
06970006746070TopCEM Vigor SA Self-Adhesive Resin Cement/TR (Translucent)/9g2026-04-22
06970006746087TopCEM Vigor SA Self-Adhesive Resin Cement/A0 (Light+)/9g2026-04-22
06970006746094TopCEM Vigor SA Self-Adhesive Resin Cement/A1 (Light)/9g2026-04-22
06970006746100TopCEM Vigor SA Self-Adhesive Resin Cement/A2 (Medium)/9g2026-04-22
06970006746117TopCEM Vigor SA Self-Adhesive Resin Cement/A3 (Dark)/9g2026-04-22
06970006746124TopCEM Vigor SA Self-Adhesive Resin Cement/White (White Opaque)/9g2026-04-22
06970006746131TopCEM Vigor SA Self-Adhesive Resin Cement/Opaque (Universal Opaque)/9g2026-04-22
06972220489375Enamel Coating ResinW-VSM-Enamel Coating ResinTyoe F/1.5ml*12025-10-27
06972220488972Ceramic Coupling AgentW-VSM5ml2025-10-27
06970006744595TrusFIL Universal Composite RestorativeEA2-4g2025-10-30
06972220489092TrusFIL Universal Composite RestorativeA2-4g2025-10-30
06972220489108TrusFIL Universal Composite RestorativeA3-4g2025-10-30
06972220489115TrusFIL Universal Composite RestorativeA3.5-4g2025-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456224366JMUJMU DENTAL, INCKLE2026-07-22
00840456224441JMUJMU DENTAL, INCKLE2026-07-22
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00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00348783015614Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00850194007763Zr-P BottleVista DentalKLE2026-06-04
08809518342105Hi-Bond UniversalMEDICLUS CO.,LTDKLE2026-06-01
00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
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D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24
D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14