FDA UDI
In Commercial Distribution
🇺🇸 United States
DYNAMIC ABUTMENT SOLUTIONS
DI: 08435673510150
·
Model: 75.119.024.48-2
·
TALLADIUM ESPAÑA SL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DYNAMIC ABUTMENT SOLUTIONS
- Primary DI
- 08435673510150
- Version / Model
- 75.119.024.48-2
- Company Name
- TALLADIUM ESPAÑA SL
- Labeler DUNS
- 510591266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-29
- Public Version
- 2
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- 3339ddc6-3c41-46b9-9e18-5a4c67ee031b
Device Description
Implant Mount Offset 10mm. Comp.0024-B1
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64627 | Dental implant holding endpiece, reusable | A device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft with an opening at its distal end designed to be mounted onto the distal end of a manual screwdriver or power tool whereby rotation is applied to introduce the implant into a surgical cavity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08435673510150 | GS1 |
Customer Contacts
- Phone
- +34973289580
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius