The following data is part of a premarket notification filed by Lk Consulting Group Usa, Inc. with the FDA for Jr Implant System.
| Device ID | K130694 |
| 510k Number | K130694 |
| Device Name: | JR IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LK Consulting Group USA, Inc. 1515 E KATELLA AVE. UNIT 2115 Anaheim, CA 92805 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1515 E KATELLA AVE. UNIT 2115 Anaheim, CA 92805 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-14 |
| Decision Date | 2014-06-19 |
| Summary: | summary |