FDA.reportPublic FDA data

Duo-Link Universal

Primary DI
00810111540865
Brand
Duo-Link Universal
Company
BISCO INC.
Model
A-19031PS
Catalog number
A-19031PS
Device description
Duo-Link Universal 1g Universal Dual Syr. Pkg
Published
2022-08-01
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D757A19031PS1PreviousHIBCC0
00810111540865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111540865008101115408658101115408650810111540865

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)534-6000sales@bisco.com

Regulatory Flags#

DUNS number
053529939
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111543323QuantiumH-100A2SH-100A2S2025-07-29
00810111543330QuantiumH-110A2SH-110A2S2025-07-29
00810111543347QuantiumH-110A2PSH-110A2PS2025-07-29
10810111541500Aelite Aesthetic EnamelH-852B4H-852B42023-01-16
10810111541548Aelite Aesthetic EnamelH-852FRH-852FR2023-01-16
10810111542255eCementC-5201C-52012023-01-17
20810111541606Aelite Aesthetic EnamelH-854A4H-854A42023-01-16
20810111541637Aelite Aesthetic EnamelH-854B3H-854B32023-01-16
20810111541644Aelite Aesthetic EnamelH-854B4H-854B42023-01-16
20810111541651Aelite Aesthetic EnamelH-854D2H-854D22023-01-16
20810111541668Aelite Aesthetic EnamelH-854D4H-854D42023-01-16
20810111541682Aelite Aesthetic EnamelH-854FRH-854FR2023-01-16
10810111542996QuantiumH-100A1H-100A12025-07-14
10810111543009QuantiumH-100A2H-100A22025-07-14
10810111543016QuantiumH-100A3H-100A32025-07-14
10810111543023QuantiumH-100A35H-100A352025-07-14
10810111543030QuantiumH-100B1H-100B12025-07-14
10810111543047QuantiumH-100B2H-100B22025-07-14
10810111543054QuantiumH-130BLCH-130BLC2025-07-14
10810111543061QuantiumH-110A1H-110A12025-07-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967029472RodinPac-Dent, Inc.EMA2026-03-23
00815967029656RodinPac-Dent, Inc.EMA2026-03-23
00815967029663RodinPac-Dent, Inc.EMA2026-03-23
00815967029670RodinPac-Dent, Inc.EMA2026-03-23
00815967029687RodinPac-Dent, Inc.EMA2026-03-23
00815967029694RodinPac-Dent, Inc.EMA2026-03-23
00815967029700RodinPac-Dent, Inc.EMA2026-03-23
00815967029717RodinPac-Dent, Inc.EMA2026-03-23
00815967029724RodinPac-Dent, Inc.EMA2026-03-23
07290115050400High-Q-Bond SEB.J.M. LABORATORIES LTDEMA2026-03-20
00817169021438UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00817169021445UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00840479201566GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
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09336472005450RIVA CEM AUTOMIXSDI LIMITEDEMA2026-02-16
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04560227803465iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803472iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
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