TOTALBOND

Cement, Dental

PARKELL, INC.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Totalbond.

Pre-market Notification Details

• Device ID: K990381
• 510k Number: K990381
• Device Name: TOTALBOND
• Classification: Cement, Dental
• Applicant: PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735
• Contact: Nelson J Gendusa
• Correspondent: Nelson J Gendusa; PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-02-08
• Decision Date: 1999-05-17
• Summary: summary