Identity
- Trade Name
- Root ZX3 EUDAMEDFDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- Root ZX3 EUDAMED
- Model / Reference
- RZX3-RCM EUDAMEDRZX3 Type: RCM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548213056538 EUDAMEDFDA UDI
- Basic UDI-DI
- 4548213000B0009E5 EUDAMED
- 510(k) Number
- K213477 FDA UDI
- FDA Product Code
- LQY FDA UDI
- EMDN Code
- Z12119009 APEX LOCATORS EUDAMED
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Root ZX3 by J.morita Mfg.corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4548213000B0009E5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- J. Morita Mfg. Corp.
- EUDAMED SRN
- JP-MF-000023000
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 2c61bae9-c002-4bbc-ab9c-4f802c707d45 61 fields · synced Jul 9, 2026
- FDA UDI 981dce1b-4128-42ae-a7c3-7df0963d828f 33 fields · synced May 30, 2026