Vitique
Cementation kit for definitive cementation of veneers. Veneer cementation with added value. Content: 3 syringes @ 6g Esthetic resin cement, 3 syringes @3.9g Try-In-paste, accessories.
3manufacturers in China registered for this device type
17catalogue numbers in this listing
2510(k) clearances naming this product code
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 | DMG Chemisch Pharmazeutische Fabrik Gmbh, Germany |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Manufacturer |
| 510(k) | K023649 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Close packaging immediately after use.; Storage environment temperature 15 to 25 °C; Storage environment temperature 59 to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 213042 | In distribution | |
| 213039 | In distribution | |
| 213055 | In distribution | |
| 213048 | In distribution | |
| 213038 | In distribution | |
| 213040 | In distribution | |
| 213052 | In distribution | |
| 213050 | In distribution | |
| 213044 | In distribution | |
| 213054 | In distribution | |
| 213053 | In distribution | |
| 213045 | In distribution | |
| 213049 | In distribution | |
| 213043 | In distribution | |
| 213051 | In distribution | |
| 213041 | In distribution | |
| 213081 | 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 |
|---|---|
| K213201 | 2022-06-01 |
| K991172 | 1999-05-17 |
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.