Sybron Dental Specialties
Sybron Dental Specialties holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2018, with 2 FDA device recalls on record.
Top product codes for Sybron Dental Specialties
FDA recalls by Sybron Dental Specialties
- Z-1291-2015 — Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500
- Z-2195-2013 — AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sybron Dental Specialties
- K182826 — Ormco Spark Aligner System
- K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging System
- K160097 — Image Fast Set, Image Regular Set
- K153067 — Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
- K152956 — Pulp Canal Sealer, Pulp Canal Sealer EWT
- K152959 — Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
- K151526 — Zone, ZoneFree, Zone A1
- K151332 — Nexus Universal, Nexus Universal Chroma
- K150559 — Life Fast Set, Life Regular Set
- K143209 — SonicFill 2
- K130869 — TAKE 1 ADVANCE
- K082671 — HERCULITE ULTRA
- K061042 — LINGLOCK
- K063116 — DEMETRON A.2
- K061230 — VECTORS TEMPORARY ANCHORAGE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.