Panavia™ V5
Panavia V5 is an adhesive resin cement system for bonding dental restorations, including crowns, bridges, inlays, onlays, veneers, posts and cores. It can also cement restorations to…
Panavia V5 is an adhesive resin cement system for bonding dental restorations, including crowns, bridges, inlays, onlays, veneers, posts and cores. It can also cement restorations to implant abutments or frames and bond amalgam.
Its radiopaque, fluoride-releasing cement paste cures with light or chemical self-curing. An automix dispenser combines equal amounts of two components. The system also includes try-in paste and a self-etching tooth primer.
Listed Item
Introductory Kit (Universal (A2))
Shades and Priming
Five cement shades are available: Universal A2, Clear, Brown A4, White and Opaque. The Opaque shade requires self-curing for final hardening. Try-in paste approximates the hardened cement color and transparency, while the tooth primer accelerates polymerization against tooth structure.
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 | Kuraray Noritake Dental, Inc., United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| 510(k) | K150704 |
| Record published | 2017-02-17 |
| Record revised | 2021-08-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| #3608-KA | In distribution | |
| #3601-KA | In distribution | |
| #3611-KA | In distribution | |
| #3615-KA | In distribution | |
| #3612-KA | In distribution | |
| #3614-KA | In distribution | |
| #3623-KA | In distribution | |
| #3622-KA | In distribution | |
| #3605-KA | In distribution | |
| #3625-KA | In distribution | |
| #3613-KA | In distribution | |
| #3630-KA | In distribution | |
| #3635-KA | In distribution | |
| #3621-KA | In distribution | |
| #3602-KA | In distribution | |
| #3624-KA | In distribution | |
| #3604-KA | 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 |
|---|---|
| K210504 | 2021-06-11 |
| K183537 | 2019-04-25 |
| K150704 | 2015-08-21 |
| K142623 | 2015-02-26 |
| K142625 | 2015-01-27 |
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.