FDA UDI
In Commercial Distribution
🇺🇸 United States
BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
DI: 07630031724274
·
Model: Screws
·
Institut Straumann AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
- Primary DI
- 07630031724274
- Version / Model
- Screws
- Catalog Number
- 048.361V4
- Company Name
- Institut Straumann AG
- Labeler DUNS
- 483599259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 7
- Public Version Date
- 2023-04-21
- Public Version Status
- Update
- Public Device Record Key
- 62ab7c28-ef85-4998-8980-eefb40c7c5d2
Device Description
SCS Guide screw for RN synOcta® Bar coping can be shortened by 1.6 mm, L 6 mm, Ti
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
- No
- 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 |
|---|---|---|---|---|
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM | Dental | 872.3640 | 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 | 07630031724274 | GS1 | ||||
| Unit of Use | 07630031747198 | GS1 |
Customer Contacts
- Phone
- +1(800)448-8168
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894844 | 000 |