The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Jetpolisher Airpolishing Powder.
| Device ID | K875339 |
| 510k Number | K875339 |
| Device Name: | JETPOLISHER AIRPOLISHING POWDER |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | YOUNG DENTAL MANUFACTURING CO 1, LLC. 2418 NORTHLINE INDUSTRIAL BLVD Maryland Heights, MO 63043 |
| Contact | Scott Richmond |
| Correspondent | Scott Richmond YOUNG DENTAL MANUFACTURING CO 1, LLC. 2418 NORTHLINE INDUSTRIAL BLVD Maryland Heights, MO 63043 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-30 |
| Decision Date | 1988-04-18 |