Overjet Image Enhancement Assist

FDA UDI

Class II (US FDA UDI)

by Overjet

Identity

Trade Name: Overjet Image Enhancement Assist FDA UDI
Generic Name: Dental x-ray image interpretive software FDA UDI
Model / Reference: v1 FDA UDI

Identifiers

Primary DI / UDI-DI: 00860005586370 FDA UDI
FDA Product Code: QIH FDA UDI
LLZ FDA UDI
GMDN Term: Dental x-ray image interpretive software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental x-ray image interpretive software

Overjet Image Enhancement Assist by Overjet — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SMART Guide Szoftverrendszer 3.0 — Dicomlab Dental Kutatás-fejlesztési Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság · Class IIb
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Overjet Dental Assist — OVERJET · 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: Overjet

Sources (1)

FDA UDI 3130041c-426a-4b13-84fb-e6aeaa0f1cf3 32 fields · synced Jun 6, 2026