Identity
- Trade Name
- NovApex N-31 EUDAMEDNovApex FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- NovApex N-31 EUDAMEDNovApex N-31 Apex Locator FDA UDI
- Model / Reference
- NovApex EUDAMED5-N31-000 EUDAMEDN-31 FDA UDI
- Description
- NovApex N-31 Apex Locator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290114350006 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290114350006 EUDAMED
- 510(k) Number
- K121206 FDA UDI
- FDA Product Code
- LQY FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Italy 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
NovApex N-31 by Forum Engineering Technologies (96) Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290114350006 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Forum Engineering Technologies (96) Ltd.
- EUDAMED SRN
- IL-MF-000023254
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 50e1f74c-79f6-45bd-b912-d8633c00e521 61 fields · synced Jul 13, 2026
- FDA UDI 4f2b2bfd-1769-4698-a150-fb6799341571 34 fields · synced May 30, 2026