Ori

FDA UDI

Class II (US FDA UDI)

by Ori Inc

Identity

Trade Name: Ori FDA UDI
Generic Name: Intraoral optical scanning system FDA UDI
Device Name: Intraoral Optical Scanning System FDA UDI
Model / Reference: Ori One FDA UDI
Description: Intraoral Optical Scanning System FDA UDI

Identifiers

Catalog Number: 10000 FDA UDI
Primary DI / UDI-DI: 00860008859501 FDA UDI
FDA Product Code: NOF FDA UDI
GMDN Term: Intraoral optical scanning system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3661 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Intraoral optical scanning system

Ori by Ori Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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TRIOS® 4 — 3shape Trios A/S · Class II
Primescan 2 Multiuse Sleeve — Sirona Dental Systems GmbH · Class II
COMFORT+ — D.D.S., Inc. · Class II
PANDA SCANNER — Ziyang Freqty Medical Equipment Co., Ltd. · Class II
INTELLISCAN 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · 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: Ori Inc

Sources (1)

FDA UDI 3bcf2ddf-5ac4-4d3e-afb5-08b09cf93572 35 fields · synced May 30, 2026