Identity
- Trade Name
- Implantium, Superline FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Endosseous dental implant abutment FDA UDI
- Model / Reference
- AAB154520NL FDA UDI
- Description
- Endosseous dental implant abutment FDA UDI
Identifiers
- Catalog Number
- AAB154520NL FDA UDI
- Primary DI / UDI-DI
- 08809162700825 FDA UDI
- 510(k) Number
- K041368 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
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
- Outer Diameter — 4.5 Millimeter FDA UDILength — 13.31 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Implantium, Superline by Dentium Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
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Cleared under the same submission
K041368 also covers:
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Dentium Co., Ltd.
Sources (1)
- FDA UDI f6e1c870-65e4-4194-bf1b-8e498553bc01 37 fields · synced Jun 8, 2026