Identity
- Trade Name
- ROOT ELEVATOR APICAL #2/3 CH D/E 90DEG SERRATED FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Model / Reference
- 10-5036SCH FDA UDI
Identifiers
- Primary DI / UDI-DI
- D928105036SCH0 FDA UDI
- FDA Product Code
- EMJ FDA UDI
- GMDN Term
- Dental elevator, tooth/root FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental elevator, tooth/root
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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 I | Pending data |
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Manufacturer
- Manufacturer
- W.H. Holden, Inc.
Sources (1)
- FDA UDI 0a619f62-d71f-44bb-809f-ee4faf4549a4 32 fields · synced Jul 25, 2026