Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental implantation drilling template guide-sleeve FDA UDI
- Device Name
- ZI GUIDED SURGERY SLEEVE, PEEK (50un) FDA UDI
- Model / Reference
- 125.208-ET FDA UDI
- Description
- ZI GUIDED SURGERY SLEEVE, PEEK (50un) FDA UDI
Identifiers
- Catalog Number
- 125.208-ET FDA UDI
- Primary DI / UDI-DI
- 07899878064725 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implantation drilling template guide-sleeve FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.55 Millimeter FDA UDILength — 5.45 Millimeter FDA UDI
Category: Dental implantation drilling template guide-sleeve
Neodent by JJGC Indústria e Comércio de Materiais Dentários S/A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
Sources (1)
- FDA UDI 3d558ab8-4025-45f6-9d87-26ad67fd62d8 37 fields · synced May 31, 2026