The following data is part of a premarket notification filed by Premium Plus International Limited with the FDA for Premium Plus Prophy Air Motor.
| Device ID | K170261 |
| 510k Number | K170261 |
| Device Name: | Premium Plus Prophy Air Motor |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG, N.T. Hong Kong, CN |
| Contact | Jessica Mao |
| Correspondent | Jessica Mao PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG, N.T. Hong Kong, CN |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D83810024NC8 | K170261 | 000 |
| D838100248 | K170261 | 000 |
| 00850061028143 | K170261 | 000 |