FDA 510(k)

PacBond One

K-Number: K210186 · 2021-07-16

Decision Date2021-07-16

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PacBond One is a medical device manufactured by Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-07-16 under approval number K210186. 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 PacBond One?

PacBond One is a medical device that received FDA 510(k) clearance on 2021-07-16. It is manufactured by Pac-Dent, Inc.. The 510(k) number is K210186.

When was PacBond One approved by the FDA?

PacBond One received FDA 510(k) clearance on 2021-07-16, under approval number K210186.

What company makes PacBond One?

PacBond One is manufactured by Pac-Dent, Inc..

What is the FDA product code for PacBond One?

The FDA product code for PacBond One is KLE.

Other Devices by Pac-Dent, Inc.

K200330RC-Prime Root Canal Preparation Cream K202831The iMask Child's Face Mask K210189Pac-Dent Denture Base Resin K210412Pac-Dent Ceramic Nanohybrid Resin K201182iMask Disposable Surgical Face Mask K202674Medidenta High Speed Handpieces

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Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc. K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172176Parkell Universal AdhesiveParkell, Inc. K172106SHOFU MZ Primer PlusShofu Dental Corporation

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.