FDA.report

Wagotrix

Primary DI
00850028211458
Brand
Wagotrix
Company
GoldenDent
Model
WFCIK
Catalog number
WFCIK
Device description
Wagoform Composite Titanium Coated Instruments #1- #4 Kit
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
JEPRETAINER, MATRIX

Product Code Classifications

CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850028211458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028211458008500282114588500282114580850028211458

GMDN Terms

TermDefinition
Dental material application tool, reusableA hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.

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
008101265081643D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081713D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081883D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081953D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
00840456215227Generic Packing (No Brand)JMU DENTAL, INCJEP2025-08-18
00840456215234Generic Packing (No Brand)JMU DENTAL, INCJEP2025-08-18
00840456213537JMUJMU DENTAL, INCJEP2025-06-25
00840456213544JMUJMU DENTAL, INCJEP2025-06-25
00840456213551JMUJMU DENTAL, INCJEP2025-06-25
00840456213568JMUJMU DENTAL, INCJEP2025-06-25
00850056330718White BiteWhite Bite, Inc.JEP2025-06-10
00850056330701White BiteWhite Bite, Inc.JEP2025-05-16
00686864061151MEDICOM SAFEMATRIXAMD Medicom IncJEP2025-03-18
10840326423858AstekYoung Innovations, Inc.JEP2025-03-17
10840326423865AstekYoung Innovations, Inc.JEP2025-03-17
10840326423872AstekYoung Innovations, Inc.JEP2025-03-17
10840326423889AstekYoung Innovations, Inc.JEP2025-03-17
00810038091129Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091136Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091143Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091150Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091167Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091174Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091181Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091198Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091204Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091211Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091228Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091235Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091242Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16