FDA.reportPublic FDA data

Hysolate

Primary DI
07630392901147
Brand
Hysolate
Company
Dent4You AG
Model
H02790
Device description
Wingless Complete Kit Latex Premium Instruments
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EEFClamp, Rubber Dam
EIEDam, Rubber
EJBHandle, Instrument, Dental
EJGForceps, Rubber Dam Clamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEFClamp, Rubber DamDental1
EIEDam, RubberDental1
EJBHandle, Instrument, DentalDental1
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630392901147PrimaryGS10
17630392901144Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630392901147076303929011477630392901147
1763039290114417630392901144

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clampA dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. This is a reusable device.

Regulatory Flags#

DUNS number
480152811
Device count
7
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640397422189HYDRIM 112W G4+ Instrument WasherG4-W10001G4-W100012026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherG4-W10001-LG4-W10001-L2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherG4-W10001-RG4-W10001-R2026-02-11
07640397421250HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01C61WD-D012025-07-22
07640397421267HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LC61WD-D01-L2025-07-22
07640397421274HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-RC61WD-D01-R2025-07-22
07640397421281HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LCSC61WD-D01-LCS2025-07-22
07640397421885HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012025-01-15
07640397421892HYDRIM C61W G4 Instrument WasherC61W-D01-LC61W-D01-L2025-01-15
07640397421908HYDRIM C61W G4 Instrument WasherC61W-D01-RC61W-D01-R2025-01-15
07640397421915HYDRIM L110W Instrument WasherL110W-D01-LL110W-D01-L2025-01-15
07640397421922HYDRIM L110W Instrument WasherL110W-D01-RL110W-D01-R2025-01-15
07640397421939HYDRIM L110W G4 Instrument WasherL110W-D01-G4L110W-D01-G42025-01-15
07640397421946HYDRIM L110W G4 Instrument WasherL110W-D01-G4-LL110W-D01-G4-L2025-01-15
07640397421953HYDRIM L110W G4 Instrument WasherL110W-D01-G4-RL110W-D01-G4-R2025-01-15
07640397421960HYDRIM L110W G4 Instrument WasherL110W-D01SH-G4L110W-D01SH-G42025-01-15
07630243601202ParaCore588658862026-07-07
07630243601219ParaCore588758872026-07-07
07630243601226ParaCore60011391600113912026-07-07
07630243601301ParaCore60011392600113922026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791032710DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032720DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G879RDC000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC14A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC201B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC202B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2060DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC206B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2070DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC207B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2080DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2090DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC210B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22