Mizzy Fleck’s
Zinc Phosphate Cement Ortho Pak 1-8oz pwd, 2-35cc liquid Golden Yellow
3manufacturers in China registered for this device type
21catalogue numbers in this listing
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 | Keystone Industries, United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2023-03-17 (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 |
| Storage | Special storage condition: Keep product from freezing |
| Sizes | Weight 29 to 227 g; total volume 15 to 35 ml; total volume 1 Gallon; weight 50 lb |
| Distribution end date | 2019-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6050300 | Weight 29 g | In distribution |
| 6051400 | Total Volume 15 ml | In distribution |
| 6050200 | Weight 29 g | In distribution |
| 6051300 | Weight 29 g | In distribution |
| 6051700 | Total Volume 35 ml | In distribution |
| 6050400 | Weight 29 g | In distribution |
| 6055900 | Weight 227 g | In distribution |
| 6053700 | In distribution | |
| 6055210 | Total Volume 1 Gallon | In distribution |
| 6053900 | In distribution | |
| 6053600 | In distribution | |
| 6055800 | Weight 227 g | In distribution |
| 6052700 | In distribution | |
| 6050100 | Weight 29 g | In distribution |
| 6055700 | Weight 227 g | In distribution |
| 6053800 | In distribution | |
| 6055600 | Weight 227 g | In distribution |
| 6070395 | Weight 50 lb | In distribution |
| 6056700 | Weight 227 g | In distribution |
| 6050900 | Weight 29 g | Withdrawn |
| 6050500 | Weight 29 g | Withdrawn |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
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.