The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil St Opaquer.
| Device ID | K012704 |
| 510k Number | K012704 |
| Device Name: | CLEARFIL ST OPAQUER |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE New York, NY 10166 |
| Contact | Masaya Sasaki |
| Correspondent | Masaya Sasaki KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE New York, NY 10166 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2001-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR000637KA1 | K012704 | 000 |
| EKUR000636KA1 | K012704 | 000 |