FDA.report

Duo-Link Universal

Primary DI
00810111540889
Brand
Duo-Link Universal
Company
BISCO INC.
Model
A-19710K
Catalog number
A-19710K
Device description
Duo-Link Universal Kit with Universal Primer
Published
2022-10-10
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

Related Records

Contact Domains

Product Codes

CodeName
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Product Code Classifications

CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D757A19710K1PreviousHIBCC0
00810111540889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111540889008101115408898101115408890810111540889

GMDN Terms

TermDefinition
Dental composite resin kitA collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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