Identity
- Trade Name
- i-ROOT 100 FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- i-ROOT 100 FDA UDI
- Model / Reference
- iRB-003 FDA UDI
- Description
- i-ROOT 100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809455600634 FDA UDI
- FDA Product Code
- LQY FDA UDI
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
i-ROOT 100 by Meta Systems Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meta Systems Co., Ltd.
Sources (1)
- FDA UDI dfe15289-ae85-41f2-998e-9d6866b45a11 34 fields · synced Jun 6, 2026