FDA UDI
In Commercial Distribution
🇺🇸 United States
Tuf-Link II
DI: 07350081494810
·
Model: TK-102
·
Dentatus AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tuf-Link II
- Primary DI
- 07350081494810
- Version / Model
- TK-102
- Catalog Number
- TK-102
- Company Name
- Dentatus AB
- Labeler DUNS
- 355803412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-10
- Public Version
- 4
- Public Version Date
- 2018-08-09
- Public Version Status
- Update
- Public Device Record Key
- 738b5041-dd12-454d-80bf-ec07b5573d5a
Device Description
TUF-LINK 10 ml syringe Silicone Material incl. 3 mixing tips for TK-G-10 Dispenser Gun
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34770 | Denture reliner, elastic, long-term | A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350081494810 | GS1 |
Customer Contacts
- Phone
- +12124811010
- [email protected]
- Phone
- +46854650900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042931 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius