Defend
Bite Registration Material Vinylpolysiloxane Derivative Super Fast Set Mint Chocolate Chip
6manufacturers in China registered for this device type
19catalogue numbers in this listing
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 | Young Innovations Inc., United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K102836 |
| Record published | 2022-10-30 |
| Record revised | 2024-04-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, box of 4, package of 8, package of 4, case of 12, box of 8 |
| Distribution end date | 2024-04-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VP-9008 | In distribution | |
| BR-9003 | In distribution | |
| BR-9002 | In distribution | |
| BR-9010 | In distribution | |
| VP-9007 | In distribution | |
| VP-9005 | In distribution | |
| VP-9004 | In distribution | |
| VP-9010 | In distribution | |
| VP-9009 | In distribution | |
| VP-9200 | In distribution | |
| VP-8006 | In distribution | |
| VP-9003 | In distribution | |
| VP-8008 | In distribution | |
| VP-9011 | In distribution | |
| BR-9200 | In distribution | |
| BR-9004 | In distribution | |
| BR-9001 | In distribution | |
| BR-9005 | In distribution | |
| BR-9003C | Withdrawn |
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
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.