FDA.reportPublic FDA data

GoldenDent

Primary DI
00850011211922
Brand
GoldenDent
Company
GoldenDent
Model
GO WGD
Catalog number
GO WGD
Device description
Weighted Graft Material Dish
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKFINSTRUMENT, CONTOURING, MATRIX, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKFInstrument, Contouring, Matrix, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011211922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011211922008500112119228500112119220850011211922

GMDN Terms#

Term, Definition table
TermDefinition
Dappen dish, reusableA small, shallow, hand-held concave vessel made of glass or metal used to mix dental materials chairside prior to application to the patient during dental procedures. The user dispenses the required amount of component materials into the device and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078273228
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850028211335WagotrixWGWL-100WGWL-1002021-02-25
00850028211342WagotrixWGWM-100WGWM-1002021-02-25
00850028211359WagotrixWGWS-100WGWS-1002021-02-25
00850011211625GoldenDentGMXRGMXR2021-02-25
00850011211939GoldenDentGO AGKGO AGK2021-02-26
00850011211830GoldenDentGO CGCGO CGC2021-02-25
00850011211946GoldenDentGO GKIGO GKI2021-02-26
00850011211823GoldenDentGO BFIGO BFI2021-02-25
00850011211915GoldenDentGO SPCGO SPC2021-02-25
00850011211403GoldenDentGK06GK062021-02-25
00850011211410GoldenDentGK08GK082021-02-25
00850011211427GoldenDentGK10GK102021-02-25
00850011211434GoldenDentGK15GK152021-02-25
00850011211441GoldenDentGK20GK202021-02-25
00850011211458GoldenDentGK25GK252021-02-25
00850011211465GoldenDentGK30GK302021-02-25
00850011211472GoldenDentGK35GK352021-02-25
00850011211489GoldenDentGK40GK402021-02-25
00850011211496GoldenDentGK45GK452021-02-25
00850011211502GoldenDentGK50GK502021-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07897990399091UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990399213UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990399220UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990301919METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990301940METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990306297METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990306303METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990308611METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990308628METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990301636PREMOLAR MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301643MOLAR MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301650DECIDUOUS MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301681METALLIC MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301698METALLIC MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301797UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301803UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301810UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301827UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301841UNIMATRIX PLIERTDV DENTAL LTDAEKF2025-02-28
07897990301872TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301889TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301896TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301902POLYESTER MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990301926METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990301933METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990306662UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306679UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306686UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306693UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990308581POLYESTER MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28