FDA UDI
In Commercial Distribution
🇺🇸 United States
BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
DI: 07630031717856
·
Model: Final Abutments
·
Institut Straumann AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
- Primary DI
- 07630031717856
- Version / Model
- Final Abutments
- Catalog Number
- 040.841
- Company Name
- Institut Straumann AG
- Labeler DUNS
- 483599259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 4
- Public Version Date
- 2019-09-02
- Public Version Status
- Update
- Public Device Record Key
- f19d2d95-1d02-48b9-a0d4-823a294f86e8
Device Description
RN Solid All-In-One Set, gray, H 5.5mm, for bridge
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 44881 | Dental implant suprastructure kit | A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630031717856 | GS1 |
Customer Contacts
- Phone
- +1(800)448-8168
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894844 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | H 5.5mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight