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FDA 510(k)

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

K-Number: K161042 · 2016-10-25

ApplicantKuraray Noritake Dental, Inc.
Decision Date2016-10-25
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2016-10-25 under approval number K161042. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack?

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack is a medical device that received FDA 510(k) clearance on 2016-10-25. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K161042.

When was CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack approved by the FDA?

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack received FDA 510(k) clearance on 2016-10-25, under approval number K161042.

What company makes CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack?

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack is manufactured by Kuraray Noritake Dental, Inc..

What is the FDA product code for CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack?

The FDA product code for CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack is KLE.

Related Clinical Trials

NCT03078426 Lung MRI in the Management of Idiopathic Pulmonary Fibrosis COMPLETED NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT06298838 High-resolution Intra-operative PSMA PET-CT in Prostate Cancer NOT_YET_RECRUITING NCT06298305 Artificial Intelligence & Prostate Cancer COMPLETED NCT06377007 Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION) COMPLETED NCT07583342 Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 25313967 The accuracy of a near-infrared spectroscopy cerebral oximetry device and its potential value for estimating jugular venous oxygen saturation. Anesthesia and analgesia (2014)

Other Devices by Kuraray Noritake Dental, Inc.

K153476KATANA AVENCIA Block K170834CERABIEN ZR K170986KATANA Zirconia Block K191980CLEARFIL MAJESTY ES Flow K191133KATANA Cleaner, KATANA Cleaner (Trial) K190436KATANA Zirconia Block

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Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172176Parkell Universal AdhesiveParkell, Inc. K172106SHOFU MZ Primer PlusShofu Dental Corporation K161077RnD TE and RnD SEApex Dental Materials, Inc.

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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