FDA.reportPublic FDA data

edelweiss Veneer 11 XS

Primary DI
09120046322582
Brand
edelweiss Veneer 11 XS
Company
edelweiss dentistry products gmbh
Model
14124
Published
2017-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
09120046322582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120046322582091200463225829120046322582

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
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
false
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 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