Overjet Periapical Radiolucency Assist
FDA UDIEUDAMEDClass II (US FDA UDI)
by Overjet
Identity
- Trade Name
- Overjet Periapical Radiolucency (PARL) Assist EUDAMEDOverjet Periapical Radiolucency Assist FDA UDI
- Generic Name
- Dental x-ray image interpretive software FDA UDI
- Device Name
- Overjet Periapical Radiolucency (PARL) Assist EUDAMED
- Model / Reference
- 1.0 EUDAMEDv1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005586332 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600055863OJOPARLAZP EUDAMED
- FDA Product Code
- MYN 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
- 892.2070 FDA UDI
- Special Device Type
- Software EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental x-ray image interpretive software
Overjet Periapical Radiolucency 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.
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- Videa Dental Assist — Videahealth, Inc. · Class II
- Overjet Image Enhancement Assist — OVERJET · Class II
- Overjet Dental Assist — OVERJET · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
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Manufacturer
- Manufacturer
- Overjet
Sources (2)
- FDA UDI c9d8f7a6-5c99-4d83-839f-78d45572221e 32 fields · synced Jul 14, 2026
- EUDAMED 6116f588-2566-4f84-a6e0-2dbadf8fa79e 61 fields · synced Jul 14, 2026