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FDA 510(k)

THE PERIOSEAL DENTAL IMPLANT

K-Number: K965032 · 1997-08-20

ApplicantPerioseal
Decision Date1997-08-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE PERIOSEAL DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Perioseal. It received FDA 510(k) clearance on 1997-08-20 under 510(k) number K965032. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PERIOSEAL DENTAL IMPLANT?

THE PERIOSEAL DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1997-08-20. The listed applicant is Perioseal. The 510(k) number is K965032.

When did THE PERIOSEAL DENTAL IMPLANT receive FDA 510(k) clearance?

THE PERIOSEAL DENTAL IMPLANT received FDA 510(k) clearance on 1997-08-20, under 510(k) number K965032.

Who is the listed applicant for THE PERIOSEAL DENTAL IMPLANT?

The FDA 510(k) record lists Perioseal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE PERIOSEAL DENTAL IMPLANT?

The FDA product code for THE PERIOSEAL DENTAL IMPLANT is DZE.

Related Clinical Trials

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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