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FDA 510(k)

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

K-Number: K152959 · 2016-04-14

ApplicantSybron Dental Specialties
Decision Date2016-04-14
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes is a medical device manufactured by Sybron Dental Specialties. It received FDA 510(k) clearance on 2016-04-14 under approval number K152959. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes?

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes is a medical device that received FDA 510(k) clearance on 2016-04-14. It is manufactured by Sybron Dental Specialties. The 510(k) number is K152959.

When was Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes approved by the FDA?

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes received FDA 510(k) clearance on 2016-04-14, under approval number K152959.

What company makes Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes?

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes is manufactured by Sybron Dental Specialties.

What is the FDA product code for Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes?

The FDA product code for Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes is KIF.

Other Devices by Sybron Dental Specialties

K160097Image Fast Set, Image Regular Set K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress K152956Pulp Canal Sealer, Pulp Canal Sealer EWT K162063Steri-Cassette and Steri-Cage Sterilization Packaging System K182826Ormco Spark Aligner System

Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K170950Well-Root STVericom Co., Ltd. K170207ObturysItena Clinical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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