FDA 510(k)

PLAK VAK - PV-10

K-Number: K864540 · 1987-07-02

Decision Date1987-07-02

Product CodeEFS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PLAK VAK - PV-10 is the device name listed in this FDA 510(k) record. The listed applicant is Paul S. Barclay, D.D.S. , Ltd.. It received FDA 510(k) clearance on 1987-07-02 under 510(k) number K864540. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLAK VAK - PV-10?

PLAK VAK - PV-10 is a medical device that received FDA 510(k) clearance on 1987-07-02. The listed applicant is Paul S. Barclay, D.D.S. , Ltd.. The 510(k) number is K864540.

When did PLAK VAK - PV-10 receive FDA 510(k) clearance?

PLAK VAK - PV-10 received FDA 510(k) clearance on 1987-07-02, under 510(k) number K864540.

Who is the listed applicant for PLAK VAK - PV-10?

The FDA 510(k) record lists Paul S. Barclay, D.D.S. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLAK VAK - PV-10?

The FDA product code for PLAK VAK - PV-10 is EFS.

Related Devices (Code: EFS)

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.

K023232SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLESmartpractice K001493DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001Air Force, Inc.K983374AGATHA-A-H2010Midian Intl.K964810DERMADAMUltradent Products, Inc.K952234BARRIER ALL FILMCottrell, Ltd.K943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOROral-B Laboratories

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.