FDA UDI
In Commercial Distribution
🇺🇸 United States
ZERAMEX® SB Abutment Straight, 1mm (incl. Screw)
DI: 07640161394193
·
Model: SB15501
·
Dentalpoint AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZERAMEX® SB Abutment Straight, 1mm (incl. Screw)
- Primary DI
- 07640161394193
- Version / Model
- SB15501
- Company Name
- Dentalpoint AG
- Labeler DUNS
- 483229493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-13
- Public Version
- 2
- Public Version Date
- 2023-02-06
- Public Version Status
- Update
- Public Device Record Key
- 07ec2ce9-4ead-4548-a65f-a449c20c0756
Device Description
ZERAMEX® SB Abutment Straight, 1mm (incl. Screw)
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 |
|---|---|---|---|---|
| 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 | 07640161394193 | GS1 |