ACRYLIC

Crown And Bridge, Temporary, Resin

INOVATIV, LLC

The following data is part of a premarket notification filed by Inovativ, Llc with the FDA for Acrylic.

Pre-market Notification Details

• Device ID: K024282
• 510k Number: K024282
• Device Name: ACRYLIC
• Classification: Crown And Bridge, Temporary, Resin
• Applicant: INOVATIV, LLC 1155 TWIN HILLS DR. Jefferson, OR 97352
• Contact: Robert Bowers
• Correspondent: Robert Bowers; INOVATIV, LLC 1155 TWIN HILLS DR. Jefferson, OR 97352
• Product Code: EBG
• CFR Regulation Number: 872.3770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-12-23
• Decision Date: 2003-03-21
• Summary: summary