FDA UDI
In Commercial Distribution
🇺🇸 United States
SciPharm Fluoroseal Cavity Liner
DI: D801SP75131B1
·
Model: SP 75-131 B
·
SCIENTIFIC PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SciPharm Fluoroseal Cavity Liner
- Primary DI
- D801SP75131B1
- Version / Model
- SP 75-131 B
- Catalog Number
- 75-131
- Company Name
- SCIENTIFIC PHARMACEUTICALS, INC.
- Labeler DUNS
- 096010525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 07e3013b-ede9-4ce1-929b-044a149d78ae
Device Description
Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Contrast Shade Syringe. Boxed.
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
- Yes
- 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 | D801SP75131B1 | HIBCC |
Customer Contacts
- Phone
- 800-634-3047
- [email protected]
- Phone
- 909-595-9922
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K860633 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 75 Degrees Fahrenheit