Young Dental
Disclosing Tablets, Zooby Dual Detection, 250ct
5manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen JIE Bishi Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Omedic Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Repacker / relabeller | 8 |
| Xingyue Medical Health Technology (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| Anhui Greenland Biotech Co., Ltd. | Bengbu | Anhui | Manufacturer | 6 |
| Shandong Tongshun Medical Equipment Co., Ltd. | Weifang | Shandong | Contract manufacturer | 2 |
Record
| Listed by | Young Dental Manufacturing I, LLC |
|---|---|
| FDA product code | QJC |
| Device type | Plaque Disclosing Agent |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6855 |
| Premarket notification | Exempt |
| Record published | 2025-02-17 |
| Record revised | 2025-08-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 35000, case of 60, case of 12, inner of 1000, case of 25, inner |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 234200 | In distribution | |
| 233004 | In distribution | |
| 234225 | In distribution | |
| 233102 | In distribution | |
| 295718 | In distribution | |
| 232210 | In distribution | |
| 232225 | In distribution | |
| 232200 | In distribution | |
| 231102 | In distribution | |
| 234210 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Quick-Detect | Hager Worldwide, Inc. | 4 |
| HurriView | Beutlich Pharmaceuticals, LLC | 1 |
| Disclosing Tablets – 100 pieces | Produits dentaires S.A. | 1 |
| CaviSense | Cavisense, Inc | 1 |
| Disclosing Tablets – 1’000 pieces | Produits dentaires S.A. | 1 |
| Disclosing Tablets – 500 pieces | Produits dentaires S.A. | 1 |
| HurriView II | Beutlich Pharmaceuticals, LLC | 1 |
| Young Innovations | Young Innovations Inc. | 1 |
| GUM® | Sunstar Americas, Inc. | 1 |
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.