The following data is part of a premarket notification filed by Infinitt Co., Ltd. with the FDA for Xelis Dental.
| Device ID | K102684 |
| 510k Number | K102684 |
| Device Name: | XELIS DENTAL |
| Classification | System, Image Processing, Radiological |
| Applicant | INFINITT CO., LTD. 12F DAERUNG POST TOWER III 182-4 GURO-DONG, GURO-GU Seoul, KR 152-050 |
| Contact | Tristan Choi |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-09-17 |
| Decision Date | 2010-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809278790116 | K102684 | 000 |