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

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
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06942201747008FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
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06942201747039FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747107FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747121FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747138FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747213FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747220FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747299FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747312FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747411FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747428FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747480FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747503FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747510FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747602FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747619FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747718FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747770FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747787FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747794FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747800FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
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06942201747909FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747961FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747985FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03