FDA.reportPublic FDA data

Temporary Crown and Bridge Resin

Primary DI
06970006744557
Brand
Temporary Crown and Bridge Resin
Company
Rizhao HuGe Biomaterials Company, Ltd.
Model
10:1
Catalog number
A2-70g
Published
2025-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251271000TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.2025-06-23EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970006744557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970006744557069700067445576970006744557

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridge resinA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

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
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02