SEALITE

Sealant, Pit And Fissure, And Conditioner

SYBRON CORP.

The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Sealite.

Pre-market Notification Details

• Device ID: K862284
• 510k Number: K862284
• Device Name: SEALITE
• Classification: Sealant, Pit And Fissure, And Conditioner
• Applicant: SYBRON CORP. C/O NIXON,HARGRAVE,DEVANS & DOYLE, SUITE 800, 1 THOMAS CIR Washington, DC 20005
• Contact: Kurzman, Pc
• Correspondent: Kurzman, Pc; SYBRON CORP. C/O NIXON,HARGRAVE,DEVANS & DOYLE, SUITE 800, 1 THOMAS CIR Washington, DC 20005
• Product Code: EBC
• CFR Regulation Number: 872.3765 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-06-16
• Decision Date: 1986-06-23