The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for K-etchant Gel.
| Device ID | K062409 |
| 510k Number | K062409 |
| Device Name: | K-ETCHANT GEL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
| Contact | Koji Nishida |
| Correspondent | Koji Nishida KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-17 |
| Decision Date | 2006-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR000013KA1 | K062409 | 000 |