FDA UDI
In Commercial Distribution
🇺🇸 United States
Simpleline II Abutment System
DI: 08809162702805
·
Model: BIC3L
·
Dentium Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Simpleline II Abutment System
- Primary DI
- 08809162702805
- Version / Model
- BIC3L
- Catalog Number
- BIC3L
- Company Name
- Dentium Co., Ltd.
- Labeler DUNS
- 689514395
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-25
- Public Version
- 1
- Public Version Date
- 2019-08-02
- Public Version Status
- New
- Public Device Record Key
- e0f87f31-a184-49eb-9b90-1ec8e8988505
Device Description
Endosseous Dental Implant Abutment
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64321 | Dental precision attachment simulator/analog, single-use | A device intended to be used to imitate or copy a dental precision attachment, or element that is part of a precision attachment, during fabrication of a final dental prosthesis (e.g., denture, crown, bridge) in the dental laboratory. It may be an instrument designed to reproduce the position, shape, and dimensions of a precision attachment, or it may be a copy of a precision attachment designed to enable fabrication of, or correct incorporation of, the final precision attachment in the dental prosthesis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809162702805 | GS1 |
Customer Contacts
- Phone
- +1(714)226-0229
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112045 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.3 | Millimeter | |
| Outer Diameter | 4.65 | Millimeter |