The following data is part of a premarket notification filed by Pac-dent International (suzhou), Ltd. with the FDA for Proangle Disposable Prophy Angle.
| Device ID | K030603 |
| 510k Number | K030603 |
| Device Name: | PROANGLE DISPOSABLE PROPHY ANGLE |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | PAC-DENT INTERNATIONAL (SUZHOU), LTD. 125 BINHE ROAD NEW DISTRICT OF SUZHOU CITY Jiangsu Province, CN 215011 |
| Contact | Xu Wang |
| Correspondent | Xu Wang PAC-DENT INTERNATIONAL (SUZHOU), LTD. 125 BINHE ROAD NEW DISTRICT OF SUZHOU CITY Jiangsu Province, CN 215011 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2003-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20304040142671 | K030603 | 000 |
| 00850046903427 | K030603 | 000 |
| 00732224000060 | K030603 | 000 |
| 00732224000077 | K030603 | 000 |
| 00732224000084 | K030603 | 000 |
| 50732224002939 | K030603 | 000 |
| 00850046903366 | K030603 | 000 |
| 00850046903373 | K030603 | 000 |
| 00850046903380 | K030603 | 000 |
| 50732224000362 | K030603 | 000 |
| 50732224000379 | K030603 | 000 |
| 50732224002915 | K030603 | 000 |
| 50732224002922 | K030603 | 000 |
| 50732224002946 | K030603 | 000 |
| 50732224002953 | K030603 | 000 |
| 20304040142664 | K030603 | 000 |
| 00850046903410 | K030603 | 000 |