Duo-Link Universal

FDA UDI

Class I (US FDA UDI)

by Bisco Inc.

Identity

Trade Name: Duo-Link Universal FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Duo-Link Universal 8g Milky White Dual Syr. Pkg FDA UDI
Model / Reference: A-197MWP FDA UDI
Description: Duo-Link Universal 8g Milky White Dual Syr. Pkg FDA UDI

Identifiers

Catalog Number: A-197MWP FDA UDI
Primary DI / UDI-DI: 00810111540841 FDA UDI
FDA Product Code: EID FDA UDI
EMA FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
872.3275 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental composite resin

Duo-Link Universal by Bisco Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bisco Inc.

Sources (1)

FDA UDI 1bc65d20-e0f9-4835-a339-633b079b7653 36 fields · synced Jun 8, 2026