FDA.reportPublic FDA data

Wagotrix

Primary DI
00850028211250
Brand
Wagotrix
Company
GoldenDent
Model
WGM55-25
Catalog number
WGM55-25
Device description
5.5mm Curved Matrix Re-Fill Qty 25
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
00850028211250PrimaryGS10
00850028211922Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028211250008500282112508500282112500850028211250
00850028211922008500282119228500282119220850028211922

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, reusableA band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078273228
Device count
25
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