Premier® Absorbent Points
Points Absorb Sterile Xcoarse
35manufacturers in China registered for this device type
7catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (5), Shanghai (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Dentsply Dental (Tianjin) Co., Ltd. | Teda | Tianjin | Contract manufacturer | 2 |
| Tianjin Diadent Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 2 |
| Bazhou City Xin an Town Hexin Medical Material Factory | Hebei | Hebei | Contract manufacturer | 1 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
Showing 12 of 35. All 35 manufacturers in China registered for Point, Paper, Endodontic
Record
| Listed by | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EKN |
| Device type | Point, Paper, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3830 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-01-09 |
| Record revised | 2024-04-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9055106 | In distribution | |
| 9055102 | In distribution | |
| 9055101 | In distribution | |
| 9055104 | In distribution | |
| 9055109 | In distribution | |
| 9055105 | In distribution | |
| 9055103 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Absorbent Paper Points | Diadent Group Intl., Inc. | 1,092 |
| MM Marked Paper Points | Diadent Group Intl., Inc. | 644 |
| Henry Schein | Henry Schein, Inc. | 198 |
| Safco absorbent points | Safco Dental Supply | 136 |
| Zarc | Shanghai Xing YU Medical Equipment Co., Ltd. | 110 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 106 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 96 |
| Hygenic® Paper Points | Coltène/Whaledent AG | 73 |
| Endodontic Absorbent Paper Points | Tulsa Dental Products LLC | 71 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 63 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 60 |
| Avalon Biomed | Shanghai Xing YU Medical Equipment Co., Ltd. | 58 |
Showing 12 of 471. All products under Point, Paper, Endodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K800827 | 1980-04-29 |
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.