FDA.reportPublic FDA data

"TEMREX BRASS ""T"" MATRIX BAND"

Primary DI
00850015110634
Brand
"TEMREX BRASS ""T"" MATRIX BAND"
Company
TEMREX CORPORATION
Model
91-96
Device description
A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.
Published
2022-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015110634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015110634008500151106348500151106340850015110634

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012072823
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015110092GENTLE-ETCH7210 SYRINGE2020-02-13
00850015110320TEMREX GENTLE ETCH 7200 KIT2020-02-13
00850015110375GEL ETCH 6500 KIT2020-02-12
00850015110382GEL ETCH 6510 SYRINGE2020-02-12
00850015110399GEL ETCH6575 BULK KIT2020-02-12
00850015110405GEL ETCH6580 60GM. BULK SYRINGE 2020-02-12
00850015110412GEL ETCH SEMI GEL6200 13CC BOTTLE2020-02-12
00850015110429GEL ETCH SEMI GEL6300 SYRINGE2020-02-12
00850015110023TEMREX LIQUID310 1oz.2020-02-13
00850015110030TEMREX POWDER330 25gm. White2020-02-13
00850015110047TEMREX CR PLUS7790 KIT2020-02-13
00850015110122TEMREX POWDER33I Yellow 25gm.2020-02-13
00850015110139TEMREX POWDER332 Yellow/Gray 25gm.2020-02-13
00850015110146TEMREX POWDER340 White 100gm.2020-02-13
00850015110153TEMREX POWDER341 Yellow 100gm.2020-02-13
00850015110160TEMREX POWDER350 White 1lb.2020-02-13
00850015110177TEMREX POWDER351 Yellow 1lb.2020-02-13
00850015110184TEMREX POWDER352 Yellow/Gray 1lb.2020-02-13
00850015110214ZINROC POWDER430 White 25gm.2020-02-13
00850015110221ZINROC POWDER431 Lt. Yellow 25gm.2020-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000661Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000838Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000883Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001040Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22