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FDA 510(k)

PacBond One

K-Number: K210186 · 2021-07-16

ApplicantPac-Dent, Inc.
Decision Date2021-07-16
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PacBond One is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-07-16 under 510(k) 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. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K210186.

When did PacBond One receive FDA 510(k) clearance?

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

Who is the listed applicant for PacBond One?

The FDA 510(k) record lists Pac-Dent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PacBond One?

The FDA product code for PacBond One is KLE.

Other records listing Pac-Dent, Inc. as applicant

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Related Devices (Code: KLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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