FDA UDI
In Commercial Distribution
🇺🇸 United States
Tenure®
DI: D8130304129010
·
Model: 030412901
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tenure®
- Primary DI
- D8130304129010
- Version / Model
- 030412901
- Catalog Number
- 030412901
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- d3a6ae21-0a73-42fc-a1c1-f95c8c4c5cf4
Device Description
TENURE UBOND SOL A 6mL RFL KIT
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
- Yes
- 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 |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34782 | Dentine bonding agent/set | A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. 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 | D8130304129010 | HIBCC |
Customer Contacts
- Phone
- 1-800-433-6628
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K801216 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze or refrigerate
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to temperatures exceeding 80° F (27° C).
- Type
- Special Storage Condition, Specify
- Special Conditions
- " Do not expose to direct sunlight.."
- Type
- Special Storage Condition, Specify
- Special Conditions
- Recommended temperature when used is 70° - 75° F (21° - 24° C).