FDA.report

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
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EIEDam, Rubber

Product Code Classifications

CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630392900539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630392900539076303929005397630392900539

GMDN Terms

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

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

Regulatory Flags

DUNS number
480152811
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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07630243600595BRILLIANT Crios60019985600199852026-02-10
07630243600601BRILLIANT Crios60019986600199862026-02-10
07630243600618BRILLIANT Crios60019987600199872026-02-10
07630243600625BRILLIANT Crios60019988600199882026-02-10
07630243600632BRILLIANT Crios60019989600199892026-02-10
07630243600649BRILLIANT Crios60019990600199902026-02-10
07630243600656BRILLIANT Crios60019991600199912026-02-10
07630243600663BRILLIANT Crios60019992600199922026-02-10
07630243600670BRILLIANT Crios60019993600199932026-02-10
07630243600687BRILLIANT Crios60019994600199942026-02-10
07630243600694BRILLIANT Crios60019995600199952026-02-10
07630243600700BRILLIANT Crios60019996600199962026-02-10
07630243600717BRILLIANT Crios60019997600199972026-02-10
07630243600724BRILLIANT Crios60019998600199982026-02-10
07630243600731BRILLIANT Crios60019999600199992026-02-10

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07630392912112HySolateDent4You AGEIE2025-12-18
17630392912126HySolateDent4You AGEIE2025-12-18
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00359883001384True™ Dental Dam Latex 6x6DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001391True™ Dental Dam Latex 6x6 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001407True™ Dental Dam Latex 5x5DEN-MAT HOLDINGS, LLCEIE2025-03-12
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00359883006709EdgeDam™ Refill Heavy 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
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00359883006754EdgeDam™ Sample Heavy 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006761EdgeDam™ Sample Medium 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
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