FDA UDI
In Commercial Distribution
🇺🇸 United States
SciPharm Anterior/Posterior Composite Resin Paste/Paste
DI: D80150041
·
Model: SP 50-04
·
SCIENTIFIC PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SciPharm Anterior/Posterior Composite Resin Paste/Paste
- Primary DI
- D80150041
- Version / Model
- SP 50-04
- Catalog Number
- 50-04
- Company Name
- SCIENTIFIC PHARMACEUTICALS, INC.
- Labeler DUNS
- 096010525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- aab876ff-9e41-4527-9209-5036d69fafa4
Device Description
Anterior/Posterior Resin Based Restorative Material
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBD | Coating, Filling Material, Resin | Dental | 872.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16725 | Self-cured dental restorative composite resin | A dental restorative material consisting of a blend of glass or ceramic particles dispersed in a synthetic, self-polymerizable, organic resin matrix that is typically used to fill dental cavities or restore damaged dental tissue. It is typically a two-paste system (self-cured when put together) consisting basically of a dimethacrylate resin [(e.g., a bisphenol A and glycidylmethacrylate (BIS-GMA)]; the filler is usually made of glass, quartz, or ceramic. Typically, one paste contains an accelerator and the other a catalyst which polymerize a solid resin. This single-use product should match the colour of the original teeth for aesthetic reasons. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D80150041 | HIBCC |
Customer Contacts
- Phone
- 800-634-3047
- [email protected]
- Phone
- 909-595-9922
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K791078 | 000 |