FDA.reportPublic FDA data

HySolate

Primary DI
07630392912136
Brand
HySolate
Company
Dent4You AG
Model
60037568
Device description
HySolate SyntX Dam non-latex blue medium 6''x 6'' (152 x 152 mm), 75 pcs
Published
2025-12-18
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
07630392912136PrimaryGS10
17630392912133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630392912136076303929121367630392912136
1763039291213317630392912133

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, non-latexA sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.

Regulatory Flags#

DUNS number
480152811
Device count
75
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
07640397420390HIP Ultra Cleaning SolutionCS-HIPC-UCS-HIPC-U2026-05-06
07640397420406HIP Cleaning SolutionCS-HIPLCS-HIPL2026-05-06
07640397422332HIP Cleaning SolutionCS-HIPTCS-HIPT2026-02-11
07630243627981BRILLIANT EverGlow60019697600196972026-04-28
07630243627998BRILLIANT EverGlow60019698600196982026-04-28
07630243628001BRILLIANT EverGlow60019699600196992026-04-28
07630243628018BRILLIANT EverGlow60019700600197002026-04-28
07630243628025BRILLIANT EverGlow60019701600197012026-04-28
07630243628032BRILLIANT EverGlow60019702600197022026-04-28
07630243628049BRILLIANT EverGlow60019703600197032026-04-28
07630243628056BRILLIANT EverGlow60019704600197042026-04-28
07630243628063BRILLIANT EverGlow60019705600197052026-04-28
07630243628070BRILLIANT EverGlow60019706600197062026-04-28
07630243628087BRILLIANT EverGlow60019707600197072026-04-28
07630243628094BRILLIANT EverGlow60019708600197082026-04-28
07630243628100BRILLIANT EverGlow60019709600197092026-04-28
07630243628117BRILLIANT EverGlow60019710600197102026-04-28
07630243628124BRILLIANT EverGlow60019716600197162026-04-28
07630243628131BRILLIANT EverGlow60019717600197172026-04-28
07630243628148BRILLIANT EverGlow60019718600197182026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840161302694Insti-Dam® - Latex-Free Rubber Dam - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
00840161302717Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
00840161304797Airway Armor® - Throat Guard - Small - 25 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
07630392912129HySolateDent4You AGEIE2025-12-18
10686864060298HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060304HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060311HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060328HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060335HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060342HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060359HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060366HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060373HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060380HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060397HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060403HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060410HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060427HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060434HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060441HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
07630392910781HySolateDent4You AGEIE2024-07-11
07630392910972HySolateDent4You AGEIE2024-07-11
00630094043265Bioseal Inc.BIOSEALEIE2024-01-18
10732224005581Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005598Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005604Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005611Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005628Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005635Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005642Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20