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One-Step

FDA UDI

Class II (US FDA UDI)

by Bisco Inc.

Identity

Trade Name
One-Step FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
One-Step 4ml Bottle Pkg FDA UDI
Model / Reference
U-1101P FDA UDI
Description
One-Step 4ml Bottle Pkg FDA UDI

Identifiers

Catalog Number
U-1101P FDA UDI
Primary DI / UDI-DI
10810111540930 FDA UDI
FDA Product Code
EMA FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3275 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dentine bonding agent/set

One-Step by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bisco Inc.

Sources (1)

  • FDA UDI 2e2527bf-a120-4459-b892-96c956412c27 36 fields · synced Jun 1, 2026