FDA.reportPublic FDA data

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

Product Codes#

Code, Name table
CodeName
EJBHANDLE, INSTRUMENT, DENTAL
EKFINSTRUMENT, CONTOURING, MATRIX, OPERATIVE
JEPRETAINER, MATRIX

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1
EKFInstrument, Contouring, Matrix, OperativeDental1
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850028211427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028211427008500282114278500282114270850028211427

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078273228
Device count
1
Premarket exempt
true
Kit
true
Combination product
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
00840456225400JMUJMU DENTAL, INCJEP2026-10-13
00840456225417JMUJMU DENTAL, INCJEP2026-10-13
D955MHERCS1Paul BandittTerlain Enterprises, Inc.EJB2026-09-25
D955MHM10CS1Paul BandittTerlain Enterprises, Inc.EJB2026-09-25
D955MHOCTCS1Paul BandittTerlain Enterprises, Inc.EJB2026-09-25
G8791020130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJB2026-08-14
G87910201330DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJB2026-08-14
G87910201510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJB2026-08-14
G8791020160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJB2026-08-14
00858466005592MYLTRIPDENTAMERICA, INC.JEP2026-07-27
00883205040398Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205040978Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205044617Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205044624Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205044631Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205044648Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205044655Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-26
00883205040404Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.JEP2026-06-25
08961104622142Strip PlacerMELPEX BEAUTY INSTRUMENTSEJB2026-05-21
G149TBSB1380TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1420TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1430TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB3100TBS BASICSACME ENTERPRISE.EJB2026-05-16
08809260472853TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472860TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472877TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472884TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472891TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472907TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472914TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07