Identity
- Trade Name
- i-ROOT 100 FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- PROBE CORD FOR IROOT 100 FDA UDI
- Model / Reference
- iRB-011 FDA UDI
- Description
- PROBE CORD FOR IROOT 100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809455600672 FDA UDI
- 510(k) Number
- K112508 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 |
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Manufacturer
- Manufacturer
- Meta Systems Co., Ltd.
Sources (1)
- FDA UDI 629f70b5-bdb9-45da-902f-863d58494ecd 35 fields · synced May 30, 2026