SIGNUM

Material, Tooth Shade, Resin

J.F. JELENKO & CO., INC.

The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Signum.

Pre-market Notification Details

• Device ID: K001360
• 510k Number: K001360
• Device Name: SIGNUM
• Classification: Material, Tooth Shade, Resin
• Applicant: J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504
• Contact: Raphael Judkins
• Correspondent: Raphael Judkins; J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-28
• Decision Date: 2000-06-20