Pic-N-Stic
A handle for small objects
5manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Shandong (1). 2 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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Pulpdent Corporation, United States |
|---|---|
| FDA product code | EKJ |
| Device type | Burnisher, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K911281 |
| Record published | 2021-09-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PIC | 60 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 157 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 58 |
| Power Dental USA | Power Dental U.S.A. Inc. | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 24 |
| J & J Instruments Inc | J & J Instruments, LLC | 21 |
| Pomee | Pomee Corporation | 21 |
| Zoll-Dental | Zoll-Dental | 16 |
| PDT, Inc. | PDT, Inc. | 14 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 14 |
| Henry Schein | Henry Schein, Inc. | 7 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 5 |
Showing 12 of 54. All products under Burnisher, Operative
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K911281 | 1991-05-15 |
| K901053 | 1990-05-07 |
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.