SciPharm CuRay Fil Light Cure Composite Resin
Visible Light-Cured Composite Restorative, Resin Based. With Bonding Agent. Shade A2, Boxed, Spanish
1manufacturer
9catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
Record
| Listed by | Scientific Pharmaceuticals, Inc., United States |
|---|---|
| FDA product code | EBD |
| Device type | Coating, Filling Material, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3310 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K850675 |
| Record published | 2016-07-29 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 75 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP 50-125 B | In distribution | |
| SP 50-120 | In distribution | |
| SP 50-121 | In distribution | |
| SP 50-121 N | In distribution | |
| SP 50-122 B | In distribution | |
| SP 50-120 S | In distribution | |
| SP 50-122 N | In distribution | |
| SP 50-125 BS | In distribution | |
| ID 50-121 I | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ID Lightcure System | ID Korea Co., Ltd. | 63 |
| Minute Stain | Taub Products | 56 |
| Optiglaze™ | GC America Inc. | 44 |
| Rodin | PAC-Dent Inc. | 39 |
| Renamel® Flowable Microfill | Deltamed Gmbh | 27 |
| Vita Akzent® LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 27 |
| Renamel® Flowable Microfill | Cosmedent, Inc. | 26 |
| Radica® | Dentsply LLC | 20 |
| SciPharm Support Self Cured Core Build-Up Restorative Reverse | Scientific Pharmaceuticals, Inc. | 18 |
| Renamel® Flowable Microhybrid | Cosmedent, Inc. | 16 |
| Glaze | Taub Products | 14 |
| Signum matrix | Kulzer SRL | 14 |
Showing 12 of 100. All products under Coating, Filling Material, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K850675 | 1985-03-25 |
| K823732 | 1982-12-28 |
| K791078 | 1979-08-10 |
| K791067 | 1979-08-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.