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Accessory

FDA UDI

Class I (US FDA UDI)

by Bisco Inc.

Identity

Trade Name
Accessory FDA UDI
Generic Name
Dental material mixing surface, chairside, single-use FDA UDI
Device Name
Disposable Mixing Wells - Single Well, 48pk FDA UDI
Model / Reference
X-80497P FDA UDI
Description
Disposable Mixing Wells - Single Well, 48pk FDA UDI

Identifiers

Catalog Number
X-80497P FDA UDI
Primary DI / UDI-DI
10810111542705 FDA UDI
FDA Product Code
KXR FDA UDI
GMDN Term
Dental material mixing surface, chairside, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3140 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental material mixing surface, chairside, single-use

Accessory by Bisco Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material mixing surface, chairside, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bisco Inc.

Sources (1)

  • FDA UDI 6eba6d7c-b0c8-415c-b719-dbbf8989c1c8 35 fields · synced May 30, 2026