Vitacrilic®

FDA UDI

Class II (US FDA UDI)

by Fricke International, Inc.

Identity

Trade Name: Vitacrilic® FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: RSI Monomer FDA UDI
Model / Reference: 9132-00 FDA UDI
Description: RSI Monomer FDA UDI

Identifiers

Catalog Number: 9132-00 FDA UDI
Primary DI / UDI-DI: B7159132000 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Dental appliance fabrication material, resin 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 235 Milliliter FDA UDI

Category: Dental appliance fabrication material, resin

Vitacrilic® is a dental appliance fabrication material, resin designed for the production of patient-worn dental prostheses or appliances. This heat-cured, light-cured, and self-cured material can be shaped using computer-aided design/computer-aided manufacturing (CAD/CAM) technology to create customized dentures base, occlusal splints/night guards, or drilling templates.

Similar devices

Also classified as Dental appliance fabrication material, resin.

O-Cryl Self Curing Acrylic Shade White X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
PREMIUM — Lang Dental Manufacturing Company, Inc. · Class II
Axcent Acrylics — GARRECO, LLC · Class II
smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
FREEPRINT crown A1 500g — DETAX GmbH · Class II
PREMIUM — Lang Dental Manufacturing Company, Inc. · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Fricke International, Inc.

Sources (1)

FDA UDI 65109771-06e0-46ba-8383-5ae334ffa82a 36 fields · synced Oct 6, 2026