Ex-3 Press

FDA UDI

Class II (US FDA UDI)

by Kuraray Noritake Dental Inc.

Identity

Trade Name: EX-3 PRESS FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: LnA2 2g×5 FDA UDI
Model / Reference: 108-0521KA FDA UDI
Description: LnA2 2g×5 FDA UDI

Identifiers

Primary DI / UDI-DI: EKUR1080521KA0 FDA UDI
510(k) Number: K052304 FDA UDI
FDA Product Code: EIH FDA UDI
GMDN Term: Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6660 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

Category: Dental appliance fabrication material, ceramic

Ex-3 Press by Kuraray Noritake Dental Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Kuraray Noritake Dental Inc.

Sources (1)

FDA UDI acce2b8c-b10b-482a-8535-64c1f1a0f92c 34 fields · synced May 30, 2026