FDA.report

edelweiss VENEER SET 14-24 M up

Primary DI
09120046322131
Brand
edelweiss VENEER SET 14-24 M up
Company
edelweiss dentistry products gmbh
Model
13010
Device description
SET of total 8 pcs VENEERS (1x edelweiss VENEER 14 M, 1x edelweiss VENEER 13 M, 1x edelweiss VENEER 12 M, edelweiss VENEER 11 M, edelweiss VENEER 21 M, edelweiss VENEER 22 M, edelweiss VENEER 23 M and edelweiss VENEER 24 M)
Published
2017-08-28
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

Related Records

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09120046322131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09120046322131091200463221319120046322131

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
300537672
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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 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

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