FDA.reportPublic FDA data

One Plus

Primary DI
00850079280014
Brand
One Plus
Company
Hexa Dental
Model
JB-0014
Device description
ONE Bite Registration Material 50ml, 100 Cartridges BULK, Fast Set
Published
2026-03-04
Public version status
New
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
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850079280014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850079280014008500792800148500792800140850079280014

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096955608
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850079280441HygedentUSAHD10000HD100002026-01-12
00850079280465HygedentUSAHD10005HD100052026-01-12
00850079280472HygedentUSAHD10010HD100102026-01-12
00850079280489HYgedentUSAHD10015HD100152026-01-12
00850079280496HygedentUSAHD10020HD100202026-01-12
00850057092158HexaHT-00042026-03-04
00850079280069Turbo EdgeTurbo-3162026-03-04
00850079280083Turbo EdgeTurbo-3122026-03-04
00850079280274Sure CordSure Cord Plus 12026-03-04
00850032750158HexaHT-0004HT-00042026-01-12
00008579280274sure EndoSure-Cord Plus 12026-01-22
00008579280083Turbo edgeTurbo-3122026-01-21
00085007928014One PlusJB-00142026-01-21
00085007928069Turbo EdgeTurbo-3162026-01-21
00850079280182Sure EndoSure-Cord 0002026-01-22
00850079280199Sure EndoSure-Cord 002026-01-22
00850079280205Sure endoSure- Cord 02026-01-22
00850079280212Sure EndoSure-Cord12026-01-22
00850079280229Sure endoSure-Cord 22026-01-22
00850079280236Sure EndoSure Cord Plus 000.02026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800024201986Implant Heavy BodySherpakoreaELW2023-08-03
08800024201948Precisil BigSherpakoreaELW2021-06-14
08800024201931Delikit Premium Light BodySherpakoreaELW2021-01-27
08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08