GUM®
RED-COTE® Plaque Disclosing Tablets
5manufacturers in China registered for this device type
1catalogue number
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 | Sunstar Americas, Inc., United States |
|---|---|
| FDA product code | QJC |
| Device type | Plaque Disclosing Agent |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6855 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-29 |
| Record revised | 2024-09-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Storage | Handling environment temperature up to 77 °F |
| Packaging | Box of 248 |
| Sizes | Height 10.4 mm; width 10.4 mm; depth 3.65 mm |
| Distribution end date | 2024-09-13 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 800 | Height 10.4 mm | 4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Young Dental | Young Dental Manufacturing I, LLC | 10 |
| 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 |
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.