FDA UDI
In Commercial Distribution
🇺🇸 United States
Shatkin FIRST Resin Cement Self-Cure
DI: D801SFRCB1
·
Model: SFRC
·
SCIENTIFIC PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Shatkin FIRST Resin Cement Self-Cure
- Primary DI
- D801SFRCB1
- Version / Model
- SFRC
- Catalog Number
- SFRC
- Company Name
- SCIENTIFIC PHARMACEUTICALS, INC.
- Labeler DUNS
- 096010525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-05
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- c3870352-06bf-4ac3-9851-875adcf1f90b
Device Description
Shatkin First - An Advanced Eugenol Free Solution for Permanent Crown and Bridge Cementation. Resin Adhesive. 6-gram Dual Barrel. 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 |
|---|---|---|---|---|
| EMA | Cement, Dental | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16704 | Glass ionomer dental cement | A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). 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 | D801SFRCB1 | HIBCC |
Customer Contacts
- Phone
- 18006343047
- [email protected]
- Phone
- 19095959922
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K823935 | 000 |