Hi-I®

FDA UDI

Class II (US FDA UDI)

by Fricke International, Inc.

Identity

Trade Name: HI-I® FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: Special Fibered #1 "L" HI-I® Pour FDA UDI
Model / Reference: 13029-025P FDA UDI
Description: Special Fibered #1 "L" HI-I® Pour FDA UDI

Identifiers

Catalog Number: 13029-025P FDA UDI
Primary DI / UDI-DI: B71513029025P0 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: Weight — 25 Pound FDA UDI

Category: Dental appliance fabrication material, resin

HI-I Resin Dental Appliance Fabrication Material is a heat-cured, light-cured, and self-cured dental material used for creating patient-worn and non-patient-worn dental prosthesis or appliances. It is suitable for use in the dental laboratory to manufacture a variety of devices, including dentures, relining, repairing, and rebasing. The material can be shaped using computer-aided design/computer-aided manufacturing (CAD/CAM) technology.

Similar devices

Also classified as Dental appliance fabrication material, resin.

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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

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Manufacturer

Manufacturer: Fricke International, Inc.

Sources (1)

FDA UDI fb061aed-1570-40ea-acc2-d4a823c6722d 36 fields · synced Oct 6, 2026