The following data is part of a premarket notification filed by Shanghai Dynamic Industry Co., Ltd. with the FDA for Dynamic Du Series Portable Dental Unit.
| Device ID | K111907 |
| 510k Number | K111907 |
| Device Name: | DYNAMIC DU SERIES PORTABLE DENTAL UNIT |
| Classification | Unit, Operative Dental |
| Applicant | SHANGHAI DYNAMIC INDUSTRY CO., LTD. RM 1706, NO. 128 SONGLE RD SONGJIANG AREA Shanghai, CN 201600 |
| Contact | Doris Dong |
| Correspondent | Doris Dong SHANGHAI DYNAMIC INDUSTRY CO., LTD. RM 1706, NO. 128 SONGLE RD SONGJIANG AREA Shanghai, CN 201600 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-05 |
| Decision Date | 2011-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04710739590180 | K111907 | 000 |