FDA.reportPublic FDA data

TEMREX BITE RELATOR

Primary DI
00850015110498
Brand
TEMREX BITE RELATOR
Company
TEMREX CORPORATION
Model
700, 710, 720, 760, 770, 780, 790
Device description
DENTAL IMPRESSION TRAY AND INSERT
Published
2022-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015110498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015110498008500151104988500151104980850015110498

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material kit, single-useA collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. 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

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Primary DI, Brand, Company table
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D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
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D1254304Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
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