FDA.reportPublic FDA data

Endodontic Diagnostic Instrument

Primary DI
00859611006556
Brand
Endodontic Diagnostic Instrument
Company
JORDCO INC
Model
EDXSP-S
Catalog number
EDXSP-S
Device description
e-Dx Sample Pack
Published
2020-08-08
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
00859611006556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859611006556008596110065568596110065560859611006556

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic cold test foam wedgeA section of soft, spongy, compressible material intended to be used to perform a dental cold sensitivity test for detection of a dental fracture hidden beneath tooth enamel or a cusp, and/or to assess dental pulp health. It is designed to be submitted to very low temperatures, typically by being sprayed or injected with a coolant fluid, and then applied to a patient’s tooth surface to elicit a painful response. Tweezers-like tips intended to be mounted on a hand-held instrument while holding the foam wedges may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
803063981
Device count
1
Premarket exempt
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
00859611006112EndoringERUL-sERUL-S2020-08-08
00859611006129EndoringERULX-SERULX-S2020-08-08
00859611006259EndoringERR-SERR-S2020-08-08
00859611006266EndoringERRFR-SERRFR-S2020-08-08
00859611006273EndoringERRFL-SERRFL-S2020-08-08
00859611006570EndoringERRFRRG-SERRFRRG-S2020-08-08
00859611006587EndoringERRFLRG-SERRFLRG-S2020-08-08
00859611006631EndoringERULRG-SERULRG-S2020-08-08
00859611006648EndoringERULXRG-SERULXRG-S2020-08-08
00859611006709EndoringER2SP-EX-SER2SP-EX-S2020-08-08
00859611006723EndoringER2-EX-SER2-EX-S2020-09-07
00859611006730EnodringER-EX-SER-EX-S2020-09-07
00859611006716EndogelEG-BPEG-BP2020-08-10
00859611006006EndogelEG-sEG-S2020-08-08
00859611006020EndoringER2-SER2-S2020-08-08
00859611006037EndoringER2V-SER2V-S2020-08-08
00859611006044EndoringER2Y-SER2Y-S2020-08-08
00859611006051EndoringER2G-SER2G-S2020-08-08
00859611006068EndoringER2VX-SER2VX-S2020-08-08
00859611006075EndoringER2BX-VER2BX-S2020-08-08

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