FDA.reportPublic FDA data

FenderWedge & FenderMate

Primary DI
17310236026799
Brand
FenderWedge & FenderMate
Company
Directa AB
Model
Intro-Kit
Catalog number
602679
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EJBHandle, Instrument, Dental
JEPRetainer, Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17310236026799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1731023602679917310236026799

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
353954381
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17310234131044TrollByteKimera Endo 4104/310415744131042026-09-21
17310235115869Directa Cheek Retractor Red Adult5115862022-12-07
17310235115876Directa Cheek Retractor Red Child5115872022-12-07
17310235115906Directa Cheek Retractor Ivory Adult5115902022-12-07
17310235115913Directa Cheek Retractor Ivory Child 5115912022-12-07
17310236901089ProphyCare HAp6901082025-09-01
17310231029993ProphyCare HAp6901082025-09-01
17310234160679DryDent Sublingual X-Small4160672022-12-06
17310230021967PrepSure1.0 mm2025-05-27
17310230021974PrepSure1.5 mm2025-05-27
17310230021981PrepSure2.0 mm2025-05-27
17310230924039PrepSure92403924032025-05-27
17310230004045TrollByteLynx Blue #115412450012022-12-06
17310230004052TrollByteLynx Blue #215413150022022-12-06
17310230004069TrollByteLynx Yellow #115434050012022-12-05
17310230004076TrollByteLynx Yellow #215434150022022-12-05
17310236901195ProphyCareMix Single Dose6901192022-12-07
17310230001228TrollBagPSP #1131904032022-12-06
17310230004922TrollByteEzSoft #1155005102022-12-06
17310230004946TrollByteEzSoft #2155005202022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809260472921TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
G149NP360100NPSACME ENTERPRISE.EJB2026-05-01