FDA UDI
In Commercial Distribution
🇺🇸 United States
ALPHA-DENT® Paste & Paste Orthodontic Adhesive
DI: D73530201010010
·
Model: 302.0101.001
·
DENTAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ALPHA-DENT® Paste & Paste Orthodontic Adhesive
- Primary DI
- D73530201010010
- Version / Model
- 302.0101.001
- Catalog Number
- 302.0101.001
- Company Name
- DENTAL TECHNOLOGIES, INC.
- Labeler DUNS
- 148312838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- 5b406857-868d-436e-a4c1-49d6094806ec
Device Description
ALPHA-DENT® Paste & Paste Orthodontic Adhesive is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimizes bonding failures. Kit Contains: 1 x 14g Base Paste
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
- 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 | D73530201010010 | HIBCC |
Customer Contacts
- Phone
- 847-677-5500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930614 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius