EXCITE

Agent, Tooth Bonding, Resin

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Excite.

Pre-market Notification Details

• Device ID: K990534
• 510k Number: K990534
• Device Name: EXCITE
• Classification: Agent, Tooth Bonding, Resin
• Applicant: IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228
• Contact: Peter P Mancuso
• Correspondent: Peter P Mancuso; IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-02-19
• Decision Date: 1999-03-19