Medical Device Manufacturer · US , Newport Beach , CA

Sybron Dental Specialties - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2006

Recent clearances: Ormco Spark Aligner System

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sybron Dental Specialties Dental ✕

14 devices

1-12 of 14

Cleared Oct 11, 2018

Ormco Spark Aligner System

Cleared Aug 05, 2016

Image Fast Set, Image Regular Set

Cleared Jul 27, 2016

Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress

Cleared May 06, 2016

Pulp Canal Sealer, Pulp Canal Sealer EWT

Cleared Apr 14, 2016

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

Cleared Sep 10, 2015

Zone, ZoneFree, Zone A1

Cleared Aug 17, 2015

Nexus Universal, Nexus Universal Chroma

Cleared Jun 19, 2015

Life Fast Set, Life Regular Set

Cleared Feb 05, 2015

Cleared May 30, 2013

Cleared Dec 11, 2008

HERCULITE ULTRA

Cleared Jan 19, 2007

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 07, 2026