Identity
- Trade Name
- Simpleline II Abutment System FDA UDI
- Generic Name
- Dental precision attachment simulator/analog, single-use FDA UDI
- Device Name
- Endosseous Dental Implant Abutment FDA UDI
- Model / Reference
- BIC3L FDA UDI
- Description
- Endosseous Dental Implant Abutment FDA UDI
Identifiers
- Catalog Number
- BIC3L FDA UDI
- Primary DI / UDI-DI
- 08809162702805 FDA UDI
- 510(k) Number
- K112045 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental precision attachment simulator/analog, 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
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
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
- Length — 4.3 Millimeter FDA UDIOuter Diameter — 4.65 Millimeter FDA UDI
Category: Dental precision attachment simulator/analog, single-use
Simpleline II Abutment System by Dentium Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental precision attachment simulator/analog, single-use.
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Cleared under the same submission
K112045 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 e0f87f31-a184-49eb-9b90-1ec8e8988505 37 fields · synced May 31, 2026