FDA.report

Tetric 100 Universal

Primary DI
07615208453379
Brand
Tetric 100 Universal
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
699999WW
Catalog number
699999WW
Device description
Tetric 100 Univ. Ref. 20x0.25g A3.5 Dent
Published
2023-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EBFMaterial, tooth shade, resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07615208453379PackageGS110In Commercial Distribution
DVIV699999WW1PreviousHIBCC0
07615208292961PrimaryGS10
07615208468755Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07615208453379076152084533797615208453379
07615208292961076152082929617615208292961
07615208468755076152084687557615208468755

GMDN Terms

TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
DVIV687778WW0Adhese Universal DC687778WW687778WW2026-03-17
DVIV687779WW0Adhese Universal DC687779WW687779WW2026-03-17
07615208482416OptraSculpt759593AN759593AN2026-03-13
07615208482423OptraSculpt759595AN759595AN2026-03-13
07615208590500OptraSculpt760474AN760474AN2026-03-13
07615208590678OptraSculpt760475AN760475AN2026-03-13
07615208590494OptraSculpt760476AN760476AN2026-03-13
07615208482768OptraSculpt760477AN760477AN2026-03-13
07615208315349Modeling Liquids Ceramic7015887015882026-03-05
07615208338027Modeling Liquids Ceramic6733746733742026-03-05
07615208338058Modeling Liquids Ceramic6733716733712026-03-05
07615208374292Modeling Liquids Ceramic6053666053662026-03-05
07615208488401OptraSculpt683100AN683100AN2026-01-15
07615208445596OptraSculpt683069AN683069AN2026-01-15
07615208445602OptraSculpt683068AN683068AN2026-01-15
07615208486254OptraSculpt639793AN639793AN2026-01-15
07615208445947OptraSculpt639792AN639792AN2026-01-15
07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815967025856RodinPac-Dent, Inc.EBF2026-03-24
00815967025863RodinPac-Dent, Inc.EBF2026-03-24
00815967025870RodinPac-Dent, Inc.EBF2026-03-24
00815967021438OptiCompPac-Dent, Inc.EBF2026-03-23
00815967021797OptiCompPac-Dent, Inc.EBF2026-03-23
00815967027447RodinPac-Dent, Inc.EBF2026-03-23
00815967028161RodinPac-Dent, Inc.EBF2026-03-23
00815967028178RodinPac-Dent, Inc.EBF2026-03-23
00815967028185RodinPac-Dent, Inc.EBF2026-03-23
00815967028192RodinPac-Dent, Inc.EBF2026-03-23
00815967028208RodinPac-Dent, Inc.EBF2026-03-23
00815967028215RodinPac-Dent, Inc.EBF2026-03-23
00815967028222RodinPac-Dent, Inc.EBF2026-03-23
00815967028239RodinPac-Dent, Inc.EBF2026-03-23
00815967028246RodinPac-Dent, Inc.EBF2026-03-23
00815967028253RodinPac-Dent, Inc.EBF2026-03-23
00815967028260RodinPac-Dent, Inc.EBF2026-03-23
00815967028277RodinPac-Dent, Inc.EBF2026-03-23
00815967028284RodinPac-Dent, Inc.EBF2026-03-23
00815967028291RodinPac-Dent, Inc.EBF2026-03-23
00815967028307RodinPac-Dent, Inc.EBF2026-03-23
00815967028314RodinPac-Dent, Inc.EBF2026-03-23
00815967028321RodinPac-Dent, Inc.EBF2026-03-23
00815967028338RodinPac-Dent, Inc.EBF2026-03-23
00815967028345RodinPac-Dent, Inc.EBF2026-03-23
00815967028352RodinPac-Dent, Inc.EBF2026-03-23
00815967028369RodinPac-Dent, Inc.EBF2026-03-23
00815967028376RodinPac-Dent, Inc.EBF2026-03-23
00815967028383RodinPac-Dent, Inc.EBF2026-03-23
00815967028390RodinPac-Dent, Inc.EBF2026-03-23