FDA UDI
In Commercial Distribution
🇺🇸 United States
ALPHA-DENT® Light Cure Pit & Fissure Sealant
DI: D73540101010010
·
Model: 401.0101.001
·
DENTAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ALPHA-DENT® Light Cure Pit & Fissure Sealant
- Primary DI
- D73540101010010
- Version / Model
- 401.0101.001
- Catalog Number
- 401.0101.001
- 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
- f90efb73-ae3f-4d49-bb94-360475f21634
Device Description
ALPHA-DENT® Light Cure Pit & Fissure Sealant is a hard-setting, wear resistent, un-filled resin based material that has ideal flowable viscosity for maximum coverage and protection to seal pits and fissures of teeth susceptible to caries. Kit Contains: 1 x 3ml Sealant (Opaque White)
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 |
|---|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | 872.3765 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31780 | Dental pit/fissure sealant | A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D73540101010010 | HIBCC |
Customer Contacts
- Phone
- 847-677-5500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K924635 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius