FDA UDI
In Commercial Distribution
🇺🇸 United States
ALPHA-DENT® Cavity Varnish
DI: D73540701010010
·
Model: 407.0101.001
·
DENTAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ALPHA-DENT® Cavity Varnish
- Primary DI
- D73540701010010
- Version / Model
- 407.0101.001
- Catalog Number
- 407.0101.001
- 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
- 6a9b0641-3ace-43a1-9a57-99be116b1a1c
Device Description
ALPHA-DENT® Cavity Varnish is used to form a barrier to protect exposed dentin and reduce fluid leakage around the tooth restoration interface. Kit Contains: 1 x 14ml Varnish
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 |
|---|---|---|---|---|
| LBH | Varnish, Cavity | Dental | 872.3260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35698 | Dental cavity varnish | A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. 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 | D73540701010010 | HIBCC |
Customer Contacts
- Phone
- 847-677-5500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955521 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius