Identity
- Trade Name
- Root ZX II Canal Measurement Module FDA UDI
- Generic Name
- Endodontic enlarger, reusable FDA UDI
- Model / Reference
- DP-ZX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548213013227 FDA UDI
- 510(k) Number
- K071190 FDA UDI
- FDA Product Code
- LQY FDA UDI
- GMDN Term
- Endodontic enlarger, reusable FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic enlarger, reusable
Root ZX II Canal Measurement Module by J.morita Mfg.corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endodontic enlarger, reusable.
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Cleared under the same submission
K071190 also covers:
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
- J.morita Mfg.corp.
Sources (1)
- FDA UDI aa11ced2-0cfc-4748-9199-bbb112ae5d0e 34 fields · synced Jun 1, 2026