The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc with the FDA for Young Infinity Cordless Handpiece System.
| Device ID | K171377 |
| 510k Number | K171377 |
| Device Name: | Young INFINITY Cordless Handpiece System |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Young Dental Manufacturing Co 1, LLC 13705 Shoreline CtEast Earth City, MO 63045 |
| Contact | Brian Prange |
| Correspondent | Brian Prange Young Dental Manufacturing Co 1, LLC 13705 Shoreline CtEast Earth City, MO 63045 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-10 |
| Decision Date | 2018-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302732957377 | K171377 | 000 |
| 10302732957216 | K171377 | 000 |
| 10302730001973 | K171377 | 000 |