Identity
- Trade Name
- Overjet Dental Assist (ODA) EUDAMEDOverjet Dental Assist FDA UDI
- Generic Name
- Dental x-ray image interpretive software FDA UDI
- Device Name
- Overjet Dental Assist (ODA) EUDAMED
- Model / Reference
- 1.0 EUDAMEDv1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005586301 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600055863OJODARQ EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z12110192 INSTRUMENTS FOR DENTAL TREATMENT UNITS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Dental x-ray image interpretive software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental x-ray image interpretive software
Overjet Dental Assist by Overjet — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental x-ray image interpretive software.
- Videa Perio Assist — Videahealth, Inc. · Class II
- Planungshilfe Zahnersatz (PZE) — Dampsoft GmbH · Class IIa
- Arc — Yoat Co., Ltd. · Class I
- FixR — Yoat Co., Ltd. · Class I
- SMART Guide Szoftverrendszer 3.0 — Dicomlab Dental Kutatás-fejlesztési Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság · Class IIb
- Videa Dental Assist — Videahealth, Inc. · Class II
- Overjet Periapical Radiolucency Assist — OVERJET · Class II
- Overjet Image Enhancement Assist — OVERJET · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Overjet
Sources (2)
- FDA UDI b1f48ea8-5cb6-4015-b46b-44eca29f7b58 32 fields · synced Jun 18, 2026
- EUDAMED 38f93c51-d231-4a0a-aef9-f40245f8756d 61 fields · synced Jun 18, 2026