Identity
- Trade Name
- Implantium, Superline FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Accessories, Implant, Dental, Endosseous FDA UDI
- Model / Reference
- DPU4511HL FDA UDI
- Description
- Accessories, Implant, Dental, Endosseous FDA UDI
Identifiers
- Catalog Number
- DPU4511HL FDA UDI
- Primary DI / UDI-DI
- 08809162703277 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 4.5 Millimeter FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Implantium, Superline is a high-quality dental/maxillofacial surgical procedure kit designed for reusable use in endosseous implant procedures. This comprehensive medical device directory entry provides detailed information on the Implantium, Superline, including its features, specifications, and regulatory compliance status.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 900d7320-5208-4e20-bf1e-2d8516345c64 36 fields · synced Jul 30, 2026