Fresh Bold Impression Material
FRESH Bold Impression Material Blu Max Bite Registration Cartridge
6manufacturers in China registered for this device type
27catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hygedent Inc. | Beijing | Beijing | Contract manufacturer | 1 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Chemoment Materials Co., Ltd. | Hefei | Anhui | Manufacturer | 3 |
Record
| Listed by | Exacta Dental Products, Inc., United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Repacker / relabeller |
| Record published | 2016-09-23 |
| Record revised | 2022-12-05 (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 | Per pack | Status |
|---|---|---|---|
| Monophase Cartridge | In distribution | ||
| Bite Registration | 2 | In distribution | |
| Monophase | 2 | In distribution | |
| Light Body Fast Set Cartridge | In distribution | ||
| Clear Bite Cartridge | In distribution | ||
| Heavy Body Cartridge | In distribution | ||
| Blu Max Bite Registration Cartridge | In distribution | ||
| Medium Body Fast Set | 2 | In distribution | |
| Medium Body Fast Set Bulk | 24 | In distribution | |
| Liquid Putty Bulk | 24 | In distribution | |
| Monophase Fast Set | 2 | In distribution | |
| Light Body Fast Set | 2 | In distribution | |
| Clear Bite Bulk | 24 | In distribution | |
| Heavy Body Fast Set | 2 | In distribution | |
| Heavy Body Mega Pack | In distribution | ||
| Heavy Body Fast Set Bulk | 24 | In distribution | |
| Liquid Putty | 2 | In distribution | |
| Monophase Bulk | 24 | In distribution | |
| Clear Bite | 2 | In distribution | |
| Cartridge of Bite Registration | In distribution | ||
| Medium Body Cartridge | In distribution | ||
| Light Body Fast Set Bulk | 24 | In distribution | |
| Bite Registration Bulk | 24 | In distribution | |
| Putty | In distribution | ||
| Liquid Putty Cartridge | In distribution | ||
| Monophase Fast Set Cartridge | In distribution | ||
| Monophase Fast Set Bulk | 24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 164 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 124 |
| EXAlence™ | GC America Inc. | 96 |
| MARK3 | Cargus International, Inc | 75 |
| Panasil | Kettenbach Gmbh & Co KG | 73 |
| Aquasil Ultra Smart Wetting® Impression Material Cartridge System | Dentsply LLC | 72 |
| DentMix | IPB Inc | 70 |
| Affinis | Coltène/Whaledent AG | 67 |
| Take 1 Advanced | Kerr Corporation | 54 |
| MDC Dental | MDC Dental | 49 |
| Elastomeric Impression Material | Shandong Huge Dental Material Corporation | 46 |
| Splash® | DEN-MAT Holdings, LLC | 44 |
Showing 12 of 1,245. All products under Material, Impression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K053427 | 2006-01-13 |
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.