FDA.reportPublic FDA data

Ultradent

Primary DI
05060748681997
Brand
Ultradent
Company
FOUR D RUBBER COMPANY LIMITED
Model
Medium
Catalog number
DENTALAUPIBLU01800552
Device description
DermaDam Latex Medium - 52pk
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
05060748681997PrimaryGS10
05060748684660Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060748681997050607486819975060748681997
05060748684660050607486846605060748684660

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, Hevea-latexA sheet of elastomeric material made of Hevea natural rubber latex (NRL) 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 is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
221795755
Device count
52
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
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
05060748682000UltradentHeavyDENTALAUPIBLU023006022024-12-18
05060748682017UltradentMediumDENTALFUPIBLU018005302024-12-18
05060748682024UltradentMediumDENTALFUPIBLU018005902024-12-18
05060748682031UltradentHeavyDENTALAUPIBLU018005022024-12-18
05060748682048UltradentMediumDENTALFUPIBLU018005022024-12-18
05060748682482ISODAMHeavyDENTALFGENISO023006152024-12-18
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