Identity
- Trade Name
- Simple Line II FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Accessories, Implant, Dental, Endosseous FDA UDI
- Model / Reference
- XPP162248 FDA UDI
- Description
- Accessories, Implant, Dental, Endosseous FDA UDI
Identifiers
- Catalog Number
- XPP162248 FDA UDI
- Primary DI / UDI-DI
- 08809162706582 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 21.5 Millimeter FDA UDIOuter Diameter — 4.8 Millimeter FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Simple Line II by Dentium Co., Ltd. — 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
- Manufacturer
- Dentium Co., Ltd.
Sources (1)
- FDA UDI 2a34ca4d-b510-4c7f-8d56-54b7f18fcf23 36 fields · synced Jun 8, 2026