FDA.reportPublic FDA data

Hysolate

Primary DI
07630392900539
Brand
Hysolate
Company
Dent4You AG
Model
H06525
Device description
Wedjets Stabilization cord Non-latex large, 2.1 m
Published
2023-02-28
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
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630392900539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630392900539076303929005397630392900539

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam stabilization cord, non-latexA length of non-latex material (e.g., waxed nylon dental floss) designed to stabilize/secure a rubber dam in the oral cavity during routine operative and endodontic procedures. It can be used wedge-like between the teeth and/or tied around a tooth to anchor a rubber dam to the cervical region of an exposed tooth. This device may be available in a variety of sizes and may help reduce the trauma and discomfort perceived by some patients caused through the use of metal clamps. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius26 Degrees Celsius
Special Storage Condition, Specify00Keep away from heat.
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature0 Degrees Celsius26 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480152811
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630392901437Coltolux Comfort600343932023-02-01
07630392901444Coltolux Comfort600343942023-02-01
07630392901451Coltolux Comfort600343952023-02-01
07630392901468Coltolux Comfort600343962023-02-01
07630392901406Coltolux Comfort600343902023-02-01
07630392901413Coltolux Comfort600343912023-02-01
07630392901420Coltolux Comfort600343922023-02-01
07630243660995Alpen Diamonds60032007600320072026-09-04
07630243661237Alpen Diamonds60032031600320312026-09-04
07630243662470Alpen Diamonds60032155600321552026-09-04
07630243662494Alpen Diamonds60032157600321572026-09-04
07630243662517Alpen Diamonds60032159600321592026-09-04
07630243662531Alpen Diamonds60032161600321612026-09-04
07630243662555Alpen Diamonds60032163600321632026-09-04
07630243662579Alpen Diamonds60032165600321652026-09-04
07630243662593Alpen Diamonds60032167600321672026-09-04
07630243662616Alpen Diamonds60032169600321692026-09-04
07630243662630Alpen Diamonds60032171600321712026-09-04
07630243662654Alpen Diamonds60032173600321732026-09-04
07630243662678Alpen Diamonds60032175600321752026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809262955514FineDamSpident Co., Ltd.EIE2026-10-07
D990ZVSADCK1PK0Single Arch Dam Conversion Kit 1PK, ZimVieSMART DENTURE CONVERSIONS, LLCEIE2026-06-26
06972902580062C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580079C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580093C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580109C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580116C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580123C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580130C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580147C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580154C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580161C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
07630392912129HySolateDent4You AGEIE2025-12-18
07630392912136HySolateDent4You AGEIE2025-12-18
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10686864060427HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060434HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060441HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27