Identity
- Trade Name
- Implantium, Superline FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Accessories, Implant, Dental, Endosseous FDA UDI
- Model / Reference
- XMF28H FDA UDI
- Description
- Accessories, Implant, Dental, Endosseous FDA UDI
Identifiers
- Catalog Number
- XMF28H FDA UDI
- Primary DI / UDI-DI
- 08809162705189 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Manual non-rotary dental instrument handle 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 — 28 Millimeter FDA UDI
Category: Manual non-rotary dental instrument handle
Implantium, Superline 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 bb5798b1-b142-47a1-a7ac-b7d44e657653 36 fields · synced May 30, 2026