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FDA 510(k)

Pulp Canal Sealer, Pulp Canal Sealer EWT

K-Number: K152956 · 2016-05-06

ApplicantSybron Dental Specialties
Decision Date2016-05-06
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pulp Canal Sealer, Pulp Canal Sealer EWT is a medical device manufactured by Sybron Dental Specialties. It received FDA 510(k) clearance on 2016-05-06 under approval number K152956. 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 Pulp Canal Sealer, Pulp Canal Sealer EWT?

Pulp Canal Sealer, Pulp Canal Sealer EWT is a medical device that received FDA 510(k) clearance on 2016-05-06. It is manufactured by Sybron Dental Specialties. The 510(k) number is K152956.

When was Pulp Canal Sealer, Pulp Canal Sealer EWT approved by the FDA?

Pulp Canal Sealer, Pulp Canal Sealer EWT received FDA 510(k) clearance on 2016-05-06, under approval number K152956.

What company makes Pulp Canal Sealer, Pulp Canal Sealer EWT?

Pulp Canal Sealer, Pulp Canal Sealer EWT is manufactured by Sybron Dental Specialties.

What is the FDA product code for Pulp Canal Sealer, Pulp Canal Sealer EWT?

The FDA product code for Pulp Canal Sealer, Pulp Canal Sealer EWT is KIF.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT05714384 Calcium Silicate Sealer-based Obturation in Root Canal Retreatment COMPLETED NCT04757753 Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial ACTIVE_NOT_RECRUITING NCT04945993 Tooth Retention After Root Canal Treatment With Endomethasone N ACTIVE_NOT_RECRUITING NCT04885686 Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP) COMPLETED NCT07526844 Effect of Instrumentation Systems and Sealers on Postoperative Pain NOT_YET_RECRUITING

Other Devices by Sybron Dental Specialties

K160097Image Fast Set, Image Regular Set K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress 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 K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron 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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