# Sybron Dental Specialties, Inc.

- Location (FDA's records): Orange, CA
- FDA decisions: 121 (1994–2018): 121 510(k) clearances
- Names in FDA's records: Sybron Dental Specialties, Inc. (106); Sybron Dental Specialties (15)
- Product codes: EBF (28), EMA (14), DYH (12), ELW (10), KLE (9), EBG (6), KIF (6), EJK (5), EAT (4), EBI (3), DYW (3), EBZ (3)
- 510(k) review time since 2016: median 206 days, against 212 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 20 (8 its own); citations of its devices by later devices: 71 (8 its own)
- Recalls linked to its devices: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kerr Corporation: 4 (https://510kreport.com/company/kerr)
- Symmetry Medical: 1 (https://510kreport.com/company/symmetry-medical)
- Align Technology, Inc.: 1 (https://510kreport.com/company/align-technology)
- Siemens Corp.: 1 (https://510kreport.com/company/siemens)
- Dentalez Group: 1 (https://510kreport.com/company/dentalez-group)
- A-Dec, Inc.: 1 (https://510kreport.com/company/a-dec)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- Sybron Corp.: 1 (https://510kreport.com/company/sybron)

## Firms that cite its devices most
- Prevest Denpro Limited: 4 (https://510kreport.com/company/prevest-denpro)
- Danville Materials, Inc.: 4 (https://510kreport.com/company/danville-materials)
- Lares Research, Inc.: 2 (https://510kreport.com/company/lares-research)
- 3M Company: 2 (https://510kreport.com/company/3m)
- GC America, Inc.: 2 (https://510kreport.com/company/gc-america)
- Dmg USA, Inc.: 2 (https://510kreport.com/company/dmg-usa)
- Endo Twinn B.V.: 2 (https://510kreport.com/company/endo-twinn)
- Kettenbach GmbH & Co. KG: 2 (https://510kreport.com/company/kettenbach)

## Its most-cited devices
- K182826: Ormco Spark Aligner System (2018), cited by 5
- K073478: Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements (2008), cited by 5
- K070327: Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator (2007), cited by 5
- K041474: Maxcem (2004), cited by 4
- K955331: Belleglashp (1996), cited by 3
- K010940: Sealapex 4 (2001), cited by 3

## Recent decisions
- K182826: Ormco Spark Aligner System (Oct 11, 2018)
- K162063: Steri-Cassette and Steri-Cage Sterilization Packaging System (Apr 21, 2017)
- K160097: Image Fast Set, Image Regular Set (Aug 5, 2016)
- K153067: Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress (Jul 27, 2016)
- K152956: Pulp Canal Sealer, Pulp Canal Sealer EWT (May 6, 2016)
- K152959: Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes (Apr 14, 2016)
- K151526: Zone, ZoneFree, Zone A1 (Sep 10, 2015)
- K151332: Nexus Universal, Nexus Universal Chroma (Aug 17, 2015)

Source page: https://510kreport.com/company/sybron-dental-specialties