Identity
- Trade Name
- Implantium, Superline FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Abutment, Implant, Dental, Endosseous FDA UDI
- Model / Reference
- IHAB4008H FDA UDI
- Description
- Abutment, Implant, Dental, Endosseous FDA UDI
Identifiers
- Catalog Number
- IHAB4008H FDA UDI
- Primary DI / UDI-DI
- 08809691364499 FDA UDI
- 510(k) Number
- K191634 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 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 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Implantium, Superline by Dentium Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
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- Neoss Implant System — Neoss, Ltd. · Class II
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Cleared under the same submission
K191634 also covers:
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- 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 d6152540-fc78-4603-aadd-c38ccf2f19fa 37 fields · synced May 30, 2026