Identity
- Trade Name
- Overjet Calculus Assist (OCalA) EUDAMEDOverjet Calculus Assist FDA UDI
- Generic Name
- Dental x-ray image interpretive software FDA UDI
- Device Name
- Overjet Calculus Assist (OCalA) EUDAMED
- Model / Reference
- 1.0 EUDAMEDv1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005586325 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600055863OJOCALADF 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
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 Calculus Assist by Overjet — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental x-ray image interpretive software.
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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 |
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Manufacturer
- Manufacturer
- Overjet
Sources (2)
- FDA UDI ca8c68d9-7743-4b7e-be45-029ebcb243c2 32 fields · synced Jul 21, 2026
- EUDAMED af2afd97-71f8-4dfd-8bf6-e8bac7cdbc9b 61 fields · synced Jul 21, 2026