The following data is part of a premarket notification filed by Kyungwon Medical Co., Ltd. with the FDA for Polybone Dental.
| Device ID | K092194 |
| 510k Number | K092194 |
| Device Name: | POLYBONE DENTAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | KYUNGWON MEDICAL CO., LTD. 13340 EAST FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang KYUNGWON MEDICAL CO., LTD. 13340 EAST FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2010-06-16 |
| Summary: | summary |