Ti-Core Flow Plus
Ti-Core Flow Plus is a dual-cure resin cement used for tooth-core buildup, luting and post cementation. It restores lost tooth structure in vital or nonvital teeth and can form a base for…
Ti-Core Flow Plus is a dual-cure resin cement used for tooth-core buildup, luting and post cementation. It restores lost tooth structure in vital or nonvital teeth and can form a base for an indirect restoration.
The material is supplied in double-barrel syringes, with two pastes expressed through a mixer and dispensing tip. Methacrylate resins with glass or quartz fillers use light-initiated and self-curing components.
Listed Item
Core Material and Post Cement Syrangeable Dual Cure Natural Shade A2
Restorative Applications
Indications include cementing endodontic posts, crowns, bridges, inlays and onlays. After use, the mixer and dispensing tip are discarded and the syringe cap replaced.
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | Essential Dental Systems, Inc., United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K101504 |
| Record published | 2016-07-01 |
| Record revised | 2023-11-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 60 to 85 °F |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 832-00 | Two – 9.5 gram dual barrel syringes | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152691 | 2016-02-25 |
| K101504 | 2010-10-29 |
| K922250 | 1994-01-26 |
| K922249 | 1994-01-26 |
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.