FDA UDI
In Commercial Distribution
🇺🇸 United States
Elos Accurate® Hexalobular Prosthetic Screw
DI: 05712821002136
·
Model: AS-ATEM2008A-1
·
Elos Medtech Pinol A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elos Accurate® Hexalobular Prosthetic Screw
- Primary DI
- 05712821002136
- Version / Model
- AS-ATEM2008A-1
- Company Name
- Elos Medtech Pinol A/S
- Labeler DUNS
- 306155953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-31
- Public Version
- 2
- Public Version Date
- 2020-09-22
- Public Version Status
- Update
- Public Device Record Key
- ac25bc7d-1260-4649-9127-dc20b5d522f9
Device Description
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 61647 | Dental prosthesis/implant abutment screw | A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05712821002136 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191919 | 000 |