The following data is part of a premarket notification filed by Modern Korea Co., Ltd. with the FDA for Mdk Handpieces.
| Device ID | K141886 |
| 510k Number | K141886 |
| Device Name: | MDK HANDPIECES |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MODERN KOREA CO., LTD. 2651 E. CHAPMAN AVE. STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung MODERN KOREA CO., LTD. 2651 E. CHAPMAN AVE. STE 110 Fullerton, CA 92831 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2015-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880027301317 | K141886 | 000 |
| 00880027300679 | K141886 | 000 |
| 00880027300655 | K141886 | 000 |
| 00880027300631 | K141886 | 000 |
| 00880027300617 | K141886 | 000 |
| 00880027300426 | K141886 | 000 |
| 00880027300419 | K141886 | 000 |
| 00880027300327 | K141886 | 000 |
| 00880027300310 | K141886 | 000 |
| 00880027300174 | K141886 | 000 |
| 00880027300167 | K141886 | 000 |
| 00880027300150 | K141886 | 000 |
| 00880027300129 | K141886 | 000 |
| 00880027300112 | K141886 | 000 |
| 00880027300075 | K141886 | 000 |
| 00880027300068 | K141886 | 000 |
| 00880027300051 | K141886 | 000 |
| 00880027300020 | K141886 | 000 |
| 00880027300693 | K141886 | 000 |
| 00880027300716 | K141886 | 000 |
| 00880027300785 | K141886 | 000 |
| 00880027301300 | K141886 | 000 |
| 00880027301294 | K141886 | 000 |
| 00880027301256 | K141886 | 000 |
| 00880027301188 | K141886 | 000 |
| 00880027301164 | K141886 | 000 |
| 00880027301133 | K141886 | 000 |
| 00880027301072 | K141886 | 000 |
| 00880027301027 | K141886 | 000 |
| 00880027301010 | K141886 | 000 |
| 00880027300976 | K141886 | 000 |
| 00880027300969 | K141886 | 000 |
| 00880027300891 | K141886 | 000 |
| 00880027300884 | K141886 | 000 |
| 00880027300860 | K141886 | 000 |
| 00880027300846 | K141886 | 000 |
| 00880027300839 | K141886 | 000 |
| 00880027300815 | K141886 | 000 |
| 00880027300013 | K141886 | 000 |