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
- SBC45BL FDA UDI
- Description
- Abutment, Implant, Dental, Endosseous FDA UDI
Identifiers
- Catalog Number
- SBC45BL FDA UDI
- Primary DI / UDI-DI
- 08809162703819 FDA UDI
- 510(k) Number
- K160483 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDIOuter Diameter — 4.5 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.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K160483 also covers:
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — Dentium Co., Ltd.
- Angled screw abutment — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentium Co., Ltd.
Sources (1)
- FDA UDI 6f368dc0-3c54-462a-865f-9f53bd9245ee 37 fields · synced Jun 8, 2026