ESTENIA
Material, Tooth Shade, Resin
KURARAY MEDICAL INC.
The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Estenia.
Pre-market Notification Details
| Device ID | K012707 |
| 510k Number | K012707 |
| Device Name: | ESTENIA |
| 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 | 2001-09-13 |
| Summary: | summary |
Trademark Results [ESTENIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESTENIA 75628182 2621706 Live/Registered |
KURARAY CO., LTD. 1999-01-27 |
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