Ti-Core Flow Plus Sample
Ti-Core Flow Plus is a dual-cure resin cement used for tooth core buildup, as a base before an indirect restoration and as a post cement. It can also cement endodontic posts, crowns,…
Ti-Core Flow Plus is a dual-cure resin cement used for tooth core buildup, as a base before an indirect restoration and as a post cement. It can also cement endodontic posts, crowns, bridges, inlays and onlays. This listed presentation is an A2 natural-shade sample.
The material is dispensed from a double-barrel syringe through an attached mixer and dispensing tip. Pressing the plunger expresses the cement for placement. After use, the mixer and tip are discarded and the syringe cap is replaced.
Listed Item
Core Material and Post Cement Syrangeable Dual Cure Natural Shade A2 Sample
Curing Chemistry
The resin incorporates photoinitiators including camphorquinone and ethyl 4-dimethylaminobenzoate, together with dimethylaminoethyl methacrylate. Its dual-cure formulation provides light-activated and self-curing mechanisms.
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 | 2022-10-26 (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 |
| Distribution end date | 2022-10-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 832-01 | One – 2.0 gram dual barrel syringe | Withdrawn |
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.