The following data is part of a premarket notification filed by Hallim Dentech Co., Ltd. with the FDA for Challenge-ever.
| Device ID | K102223 |
| 510k Number | K102223 |
| Device Name: | CHALLENGE-EVER |
| Classification | Unit, Operative Dental |
| Applicant | HALLIM DENTECH CO., LTD. 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung HALLIM DENTECH CO., LTD. 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-06 |
| Decision Date | 2011-02-25 |