FDA.reportPublic FDA data

edelweiss VENEER 15 L

Primary DI
09120046321172
Brand
edelweiss VENEER 15 L
Company
edelweiss dentistry products gmbh
Model
13105
Published
2017-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120046321172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120046321172091200463211729120046321172

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
300537672
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120046322414edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18)191002024-11-04
09120046322421edelweiss CAD/CAM C-BLOCK A0 (12/14/18)191012024-11-04
09120046322438edelweiss CAD/CAM C-BLOCK A1 (12/14/18)191022024-11-04
09120046322445edelweiss CAD/CAM C-BLOCK A2 (12/14/18)191032024-11-04
09120046322452edelweiss CAD/CAM C-BLOCK A3 (12/14/18)191042024-11-04
09120046322476edelweiss CAD/CAM i-BLOCK (ØS) Universal Enamel19100.A2024-11-04
09120046322483edelweiss CAD/CAM i-BLOCK (ØS) A019101.A2024-11-04
09120046322490edelweiss CAD/CAM i-BLOCK (ØS) A119102.A2024-11-04
09120046322506edelweiss CAD/CAM i-BLOCK (ØS) A219103.A2024-11-04
09120046322513edelweiss CAD/CAM i-BLOCK (ØS) A319104.A2024-11-04
09120046322537edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16)211002024-11-04
09120046322544edelweiss CAD/CAM C-BLOCK A0 (10/12/16)211012024-11-04
09120046322551edelweiss CAD/CAM C-BLOCK A1 (10/12/16)211022024-11-04
09120046322568edelweiss CAD/CAM C-BLOCK A2 (10/12/16)211032024-11-04
09120046322575edelweiss CAD/CAM C-BLOCK A3 (10/12/16)211042024-11-04
09120046325132edelweiss CAD/CAM i-BLOCK (ØL) Universal Enamel19100.A.L2024-11-04
09120046325149edelweiss CAD/CAM i-BLOCK (ØL) A019101.A.L2024-11-04
09120046325156edelweiss CAD/CAM i-BLOCK (ØL) A119102.A.L2024-11-04
09120046325163edelweiss CAD/CAM i-BLOCK (ØL) A219103.A.L2024-11-04
09120046325170edelweiss CAD/CAM i-BLOCK (ØL) A319104.A.L2024-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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