FDA.reportPublic FDA data

Triumph Resin Dam

Primary DI
D820TRI0
Brand
Triumph Resin Dam
Company
DENALI CORPORATION
Model
TRI
Catalog number
TRI
Device description
Dam, Rubber.
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D820TRI1PackageHIBCC2In Commercial Distribution
D820TRI0PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-781-826-9190denalicorp@denalicorporation.com

Regulatory Flags#

DUNS number
191036107
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D820DETCH120Denali Etching Gel12 mL Etching GelDETCH122016-08-05
D820DETCH30Denali Etching GelSyringe 3 mLDETCH32016-08-05
D820ZEN0Zenith Implant Screw MaskZEN1ZEN2023-06-13
D820ZEN1Zenith Implant Screw MaskZEN1ZEN2023-06-13
D820HIRO0HIRO Light Cure Pattern, Modeling and Indexing ResinOne 3 mL SyringeHIRO2018-01-09
D820JAZ0Jazzy DC Acrylic ResinSingle Double-Barrel SyringeJAZ2018-01-09
D820BONOW0Bonita Pit and Fissure Sealant1.2 mL Opaque WhiteBONOW2016-08-05
D820ACOREEOW0AuraCore Buildup MaterialSingle - Opaque WhiteCOREEOW2016-08-04
D820ACORENOW0AuraCore Buildup MaterialSingle - Natural Off WhiteACORENOW2016-08-04
D820ALAYNT0AuraLay Pit & Fissure Sealant 1.2 mL Natural TranslucentALAYNT2016-08-05
D820ALAYNT3ML0AuraLay Pit and Fissure Sealant3 mL Natural TranslucentALAYNT3ML2016-08-05
D820ALAYOW0AuraLay Pit and Fissure SealantOpaque White2016-08-05
D820ALAYOW3ML0AuraLay Pit and Fissure Sealant3 mL Opaque WhiteALAYOW3ML2016-08-05
D820ALAYXFNT0AuraLay XF Pit and Fissure Sealant1.2 mL Natural TranslucentALAYXFNT2016-08-05
D820ALAYXFNT3ML0AuraLay XF Pit and Fissure Sealant3 mL Natural TranslucentALAYXFNT32016-08-05
D820ALAYXFOW0AuraLay XF Pit and Fissure Sealant1.2 mL Opaque WhiteALAYXFOW2016-08-05
D820ALAYXFOW3ML0AuraLay XF Pit and Fissure Sealant3 mL Opaque White2016-08-05
D820APS0Aura Protective Sealer1.2 mL ClearAPS2016-08-05
D820BONNT0Bonita Pit and Fissure Sealant1.2 mL Natural TranslucentBONNT2016-08-05
D820BONOW1Bonita Pit and Fissure Sealant1.2 mL Opaque WhiteBONOW2016-08-05

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