Re-Cord™ Knitted Retraction Cord #2
Catalogue number 649105, listed by DEN-MAT Holdings, LLC, United States, under Floss, Dental. 151 manufacturers in China are registered for this product code.
151manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (44), Guangdong (35), Zhejiang (28). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Yuyao NEW Power Promotion Industrial Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 8 |
| Yangzhou Yichuan Plastic Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 8 |
| Yangzhou Star Oral Care Product Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 7 |
| HI-P (Xiamen) Precision Plastic Manufacturing Co., | Xiamen | Fujian | Contract manufacturer | 6 |
| Kingkey MBC Life Technology Group Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 6 |
| Yuyao Clean Commodity Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 6 |
| Hayco Industries (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yantai Yulong Commodity Co., Ltd. | Yantai | Shandong | Contract manufacturer | 5 |
Showing 12 of 151. All 151 manufacturers in China registered for Floss, Dental
Record
| Listed by | DEN-MAT Holdings, LLC, United States |
|---|---|
| FDA product code | JES |
| Device type | Floss, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6390 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2025-03-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Handling environment temperature up to 25 °C; Special storage condition: Keep away from heat, sparks and flame. |
| Sizes | Length 244 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 649105 | Length 244 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GUM® | Sunstar Americas, Inc. | 85 |
| Henry Schein | Henry Schein, Inc. | 30 |
| PRO-SYS | Benco Dental Supply Co. | 22 |
| Meijer | Meijer, Inc. | 16 |
| CareOne | Ahold U.S.A., Inc. | 14 |
| Quala | National Distribution & Contracting Inc | 13 |
| Waxed Dental Floss | Safco Dental Supply | 12 |
| Core Values | Harmon Stores, Inc. | 12 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 11 |
| TopCare | Topco Associates, LLC | 11 |
| Publix | Publix Super Markets, Inc. | 11 |
| E-Z Slide Dental Floss | Maxill, Inc. | 11 |
Showing 12 of 188. All products under Floss, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K791223 | 1979-10-09 |
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.