FDA.report

Wagotrix

Primary DI
00850028211427
Brand
Wagotrix
Company
GoldenDent
Model
WGSMEK-B
Catalog number
WGSMEK-B
Device description
Wagotrix Sectional Matrix System Essential Kit, 3.5mm anatomical matrix refill - Qty 25, 4.5mm anatomical matrix refill - Qty 25, 5.5mm anatomical matrix refill - Qty 25, 6.5mm anatomical matrix refill - Qty 25, Wedge - small - Qty 25, Wedge - medium - Qty 25, Wedge - large - Qty 25, Matrix ring universal - Qty 10
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKFINSTRUMENT, CONTOURING, MATRIX, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKFInstrument, Contouring, Matrix, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850028211427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028211427008500282114278500282114270850028211427

GMDN Terms

TermDefinition
Dental matrix band kitA collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078273228
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850011211939GoldenDentGO AGKGO AGK2021-02-26
00850011211946GoldenDentGO GKIGO GKI2021-02-26
00850011211014GoldenDentFS BFEFS BFE2021-02-25
00850011211021GoldenDentFS EF1FS EF12021-02-25
00850011211038GoldenDentFS EF2FS EF22021-02-25
00850011211045GoldenDentFS FSSFS FSS2021-02-25
00850011211052GoldenDentFS IA1FS IA12021-02-25
00850011211069GoldenDentFS IA2FS IA22021-02-25
00850011211076GoldenDentFS MTSFS MTS2021-02-25
00850011211083GoldenDentFS NCCFS NCC2021-02-25
00850011211090GoldenDentFS NCSFS NCS2021-02-25
00850011211106GoldenDentFS NTCFS NTC2021-02-25
00850011211113GoldenDentFS NTSFS NTS2021-02-25
00850011211120GoldenDentFS NUSFS NUS2021-02-25
00850011211137GoldenDentRS RFURS RFU2021-02-25
00850011211144GoldenDentFS SFCFS SFC2021-02-25
00850011211151GoldenDentFS TFUFS TFU2021-02-25
00850011211168GoldenDentGBSBGBSB2021-02-25
00850011211175GoldenDentGBSOGBSO2021-02-25
00850011211182GoldenDentGCCBGCCB2021-02-25

Other Devices Sharing Product Codes

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