The following data is part of a premarket notification filed by Chang Gung Medical Technology Co., Ltd. with the FDA for Chang Gung Commed Series Dental Implant System.
| Device ID | K142751 |
| 510k Number | K142751 |
| Device Name: | Chang Gung ComMed Series Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Chang Gung Medical Technology Co., Ltd. 11F., No. 201-4, Dun Hua North Rd. Song Shan Dist Taipei City, TW 10508 |
| Contact | Chao-chun Chiu |
| Correspondent | Chao-chun Chiu Chang Gung Medical Technology Co., Ltd. 11F., No. 201-4, Dun Hua North Rd. Song Shan Dist Taipei City, TW 10508 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-24 |
| Decision Date | 2015-06-15 |
| Summary: | summary |