FDA.reportPublic FDA data

ISODAM

Primary DI
05060748682482
Brand
ISODAM
Company
FOUR D RUBBER COMPANY LIMITED
Model
Heavy
Catalog number
DENTALFGENISO02300615
Device description
"ISODAM .23/.28mm Heavy- L.Blue 6"" x 6"" 15 pcs"
Published
2024-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
05060748682482PrimaryGS10
05060748684622Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060748682482050607486824825060748682482
05060748684622050607486846225060748684622

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.

Contacts#

Phone, Email table
PhoneEmail
+4401773763134Info@fourdrubber.com

Regulatory Flags#

DUNS number
221795755
Device count
15
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
05060748681676ISODAMX-HeavyDENTALFGENISO028006152024-12-18
05060748681683ISODAMX-HeavyDENTALFGENISO028006752024-12-18
05060748681904ISODAMThinDENTALFGENISO015005202024-12-18
05060748681935UltradentHeavyDENTALAUPIBLU018006362024-12-18
05060748681942UltradentHeavyDENTALAUPIBLU023006362024-12-18
05060748681959UltradentMediumDENTALFUPIBLU018006202024-12-18
05060748681966UltradentMediumDENTALFUPIBLU018006602024-12-18
05060748681973UltradentMediumDENTALAUPIBLU018006022024-12-18
05060748681980UltradentMediumDENTALFUPIBLU018006022024-12-18
05060748681997UltradentMediumDENTALAUPIBLU018005522024-12-18
05060748682000UltradentHeavyDENTALAUPIBLU023006022024-12-18
05060748682017UltradentMediumDENTALFUPIBLU018005302024-12-18
05060748682024UltradentMediumDENTALFUPIBLU018005902024-12-18
05060748682031UltradentHeavyDENTALAUPIBLU018005022024-12-18
05060748682048UltradentMediumDENTALFUPIBLU018005022024-12-18
05060748682499ISODAMHeavyDENTALFGENISO023006752024-12-18
05060748683540ISODAMX-HeavyDENTALFGENISO028005202024-12-18
05060748683588ISODAMThinDENTALFGENISO015006152024-12-18
05060748683595UltradentMediumDENTALAUPIBLU023006022024-12-18
05060748684394ISODAMHeavyDENTALFISPBLU023006152024-12-18

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
07630392912129HySolateDent4You AGEIE2025-12-18
07630392912136HySolateDent4You 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