The following data is part of a premarket notification filed by Premium Plus International Limited with the FDA for Premium Plus Disposable Prophy Angle Model 3399.
| Device ID | K100854 |
| 510k Number | K100854 |
| Device Name: | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | PREMIUM PLUS INTERNATIONAL LIMITED 33 WANG YIP STREET WEST YUEN LONG NT Hong Kong, CN |
| Contact | Dennis Ng |
| Correspondent | Dennis Ng PREMIUM PLUS INTERNATIONAL LIMITED 33 WANG YIP STREET WEST YUEN LONG NT Hong Kong, CN |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-26 |
| Decision Date | 2010-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D796243CS3 | K100854 | 000 |
| D796243 | K100854 | 000 |
| D796242CS3 | K100854 | 000 |
| D796242 | K100854 | 000 |