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Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Denture base resin, heat-cured FDA UDI
Device Name
ACR MON #2 15 MIN HC (8 OZ 4 PER CASE) FDA UDI
Model / Reference
1014304 FDA UDI
Description
ACR MON #2 15 MIN HC (8 OZ 4 PER CASE) FDA UDI

Identifiers

Catalog Number
1014304 FDA UDI
Primary DI / UDI-DI
H65810143040 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Denture base resin, heat-cured FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 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

Yes

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

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 8 Fluid Ounce FDA UDI

Category: Denture base resin, heat-cured

Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Denture base resin, heat-cured.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 004c4c45-4844-464b-b390-a0c983b1aa8a 36 fields · synced May 30, 2026