HeyGears

FDA UDI

Class II (US FDA UDI)

by Keystone Industries

Identity

Trade Name: HeyGears FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: KeySplint Hard for HeyGears, 1 kg FDA UDI
Model / Reference: 4220114 FDA UDI
Description: KeySplint Hard for HeyGears, 1 kg FDA UDI

Identifiers

Catalog Number: 4220114 FDA UDI
Primary DI / UDI-DI: H66842201141 FDA UDI
FDA Product Code: EBI FDA UDI
MQC FDA UDI
KMY FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 FDA UDI
872.5525 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 1 Kilogram FDA UDI
Total Volume — 35.3 Fluid Ounce FDA UDI

Category: Dental appliance fabrication material, resin

HeyGears by Keystone Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Keystone Industries

Sources (1)

FDA UDI c4f11c55-2a7d-4902-a2f9-334dc7fc9219 37 fields · synced Jun 9, 2026