RECOVER

Material, Tooth Shade, Resin

SCIENTIFIC PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Recover.

Pre-market Notification Details

• Device ID: K863401
• 510k Number: K863401
• Device Name: RECOVER
• Classification: Material, Tooth Shade, Resin
• Applicant: SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010
• Contact: Jan A Orlowski
• Correspondent: Jan A Orlowski; SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-09-03
• Decision Date: 1986-11-13