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FDA 510(k)

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

K-Number: K153067 · 2016-07-27

ApplicantSybron Dental Specialties
Decision Date2016-07-27
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress is a medical device manufactured by Sybron Dental Specialties. It received FDA 510(k) clearance on 2016-07-27 under approval number K153067. 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 Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress?

Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by Sybron Dental Specialties. The 510(k) number is K153067.

When was Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress approved by the FDA?

Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress received FDA 510(k) clearance on 2016-07-27, under approval number K153067.

What company makes Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress?

Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress is manufactured by Sybron Dental Specialties.

What is the FDA product code for Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress?

The FDA product code for Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress is KIF.

Other Devices by Sybron Dental Specialties

K160097Image Fast Set, Image Regular Set K152956Pulp Canal Sealer, Pulp Canal Sealer EWT K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes 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 K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron 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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