The following data is part of a premarket notification filed by Spident Co., Ltd. with the FDA for Temp It.
| Device ID | K100413 |
| 510k Number | K100413 |
| Device Name: | TEMP IT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SPIDENT CO., LTD. 312, 151B-6L NAMDONGGONGDAN Incheon, KR 405-821 |
| Contact | I.s. Whang |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809262954166 | K100413 | 000 |
| 08809262954173 | K100413 | 000 |