Darby Dental Supply, LLC
Absorbent Points Strip PK 40X5 45-80
35manufacturers in China registered for this device type
106catalogue numbers in this listing
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 | Darby Dental Supply, LLC |
|---|---|
| FDA product code | EKN |
| Device type | Point, Paper, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3830 |
| Premarket notification | Exempt |
| Record published | 2020-03-12 |
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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9533524 | 200 | In distribution | |
| 9533530 | 200 | In distribution | |
| 9517532 | 200 | In distribution | |
| 9533510 | 200 | In distribution | |
| 9517624 | 200 | In distribution | |
| 9533528 | 200 | In distribution | |
| 9517550 | 200 | In distribution | |
| 9533520 | 200 | In distribution | |
| 9517525 | 200 | In distribution | |
| 9533538 | 200 | In distribution | |
| 9517524 | 200 | In distribution | |
| 9517537 | 200 | In distribution | |
| 9533515 | 200 | In distribution | |
| 9517551 | 200 | In distribution | |
| 9517614 | 200 | In distribution | |
| 9517608 | 200 | In distribution | |
| 9533502 | 200 | In distribution | |
| 9517521 | 200 | In distribution | |
| 9517519 | 200 | In distribution | |
| 9517538 | 200 | In distribution | |
| 9517521 | 200 | In distribution | |
| 9533538 | 200 | In distribution | |
| 9517602 | 200 | In distribution | |
| 9517523 | 200 | In distribution | |
| 9517551 | 200 | In distribution | |
| 9517620 | 200 | In distribution | |
| 9533515 | 200 | In distribution | |
| 9517606 | 200 | In distribution | |
| 9517536 | 200 | In distribution | |
| 9517612 | 200 | In distribution | |
| 9517600 | 200 | In distribution | |
| 9517534 | 200 | In distribution | |
| 9533542 | 200 | In distribution | |
| 9517537 | 200 | In distribution | |
| 9517541 | 200 | In distribution | |
| 9533506 | 200 | In distribution | |
| 9533522 | 200 | In distribution | |
| 9517533 | 200 | In distribution | |
| 9533526 | 200 | In distribution | |
| 9533534 | 200 | In distribution | |
| 9533500 | 200 | In distribution | |
| 9517523 | 200 | In distribution | |
| 9533532 | 200 | In distribution | |
| 9533544 | 200 | In distribution | |
| 9533502 | 200 | In distribution | |
| 9517524 | 200 | In distribution | |
| 9517626 | 200 | In distribution | |
| 9517604 | 200 | In distribution | |
| 9533530 | 200 | In distribution | |
| 9517624 | 200 | In distribution | |
| 9517550 | 200 | In distribution | |
| 9517531 | 200 | In distribution | |
| 9533534 | 200 | In distribution | |
| 9533524 | 200 | In distribution | |
| 9517640 | 200 | In distribution | |
| 9517533 | 200 | In distribution | |
| 9517610 | 200 | In distribution | |
| 9533508 | 200 | In distribution | |
| 9517530 | 200 | In distribution | |
| 9517539 | 200 | In distribution | |
| 9533555 | 200 | In distribution | |
| 9533510 | 200 | In distribution | |
| 9533526 | 200 | In distribution | |
| 9517540 | 200 | In distribution | |
| 9517622 | 200 | In distribution | |
| 9517540 | 200 | In distribution | |
| 9517612 | 200 | In distribution | |
| 9517606 | 200 | In distribution | |
| 9517604 | 200 | In distribution | |
| 9533544 | 200 | In distribution | |
| 9533532 | 200 | In distribution | |
| 9533508 | 200 | In distribution | |
| 9517602 | 200 | In distribution | |
| 9517525 | 200 | In distribution | |
| 9517531 | 200 | In distribution | |
| 9533504 | 200 | In distribution | |
| 9517534 | 200 | In distribution | |
| 9517622 | 200 | In distribution | |
| 9533560 | 200 | In distribution | |
| 9533528 | 200 | In distribution | |
| 9533536 | 200 | In distribution | |
| 9517520 | 200 | In distribution | |
| 9533504 | 200 | In distribution | |
| 9517610 | 200 | In distribution | |
| 9517530 | 200 | In distribution | |
| 9517522 | 200 | In distribution | |
| 9517620 | 200 | In distribution | |
| 9517535 | 200 | In distribution | |
| 9517522 | 200 | In distribution | |
| 9517541 | 200 | In distribution | |
| 9517536 | 200 | In distribution | |
| 9517640 | 200 | In distribution | |
| 9517618 | 200 | In distribution | |
| 9517520 | 200 | In distribution | |
| 9517532 | 200 | In distribution | |
| 9517519 | 200 | In distribution | |
| 9517542 | 200 | In distribution | |
| 9517618 | 200 | In distribution | |
| 9517535 | 200 | In distribution | |
| 9533555 | 200 | In distribution | |
| 9533536 | 200 | In distribution | |
| 9533540 | 200 | In distribution | |
| 9517542 | 200 | In distribution | |
| 9533506 | 200 | In distribution | |
| 9517614 | 200 | In distribution | |
| 9517600 | 200 | 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 |
| 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 |
| Sure-endo | Sure Dent Corporation | 56 |
Showing 12 of 471. All products under Point, Paper, Endodontic
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.