FDA UDI
In Commercial Distribution
🇺🇸 United States
ALPHA-DENT® Light Cure Bracket Adhesive
DI: D73530302040010
·
Model: 303.0204.001
·
DENTAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
Basic Information
- Brand Name
- ALPHA-DENT® Light Cure Bracket Adhesive
- Primary DI
- D73530302040010
- Version / Model
- 303.0204.001
- Catalog Number
- 303.0204.001
- Company Name
- DENTAL TECHNOLOGIES, INC.
- Labeler DUNS
- 148312838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b5e9d780-1bff-4f33-806f-2c34f0b65af3
Device Description
ALPHA-DENT® Light Cure Bracket Adhesive is a Paste-Adhesive system formulated to bond to metal, ceramic, and plastic brackets. The unique filler combination used in the paste produces an ideal bond and a smooth tacky consistency minimizing bracket floatation. By using light cure adhesive technology we have eliminated working time contraints. Kit Contains: 40 x .35g Adhesive Unit Dose
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 |
|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 872.3750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31750 | Orthodontic bracket adhesive | A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. 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 | D73530302040010 | HIBCC | ||||
| Unit of Use | D73530304020010 | HIBCC |
Customer Contacts
- Phone
- 847-677-5500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K935625 | 000 |