ESTENIA

Material, Tooth Shade, Resin

KURARAY AMERICA, INC.

The following data is part of a premarket notification filed by Kuraray America, Inc. with the FDA for Estenia.

Pre-market Notification Details

• Device ID: K982164
• 510k Number: K982164
• Device Name: ESTENIA
• Classification: Material, Tooth Shade, Resin
• Applicant: KURARAY AMERICA, INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE New York, NY 10166
• Contact: Koji Fujita
• Correspondent: Koji Fujita; KURARAY AMERICA, 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: 1998-06-19
• Decision Date: 1998-08-10
• Summary: summary