Skip to content

PERIOCHECK Enzyme Activity Test Kit

by Actech Advanced Clinical Technologies, Inc.

PMA P870059

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P870059↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP870059 Date14 Aug 1990ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Periocheck Tm Enzyme Activity Test Kit
Generic Name
KIT, TEST, IN VITRO PERIODONTAL
PMA Number
FDA Product Code
MCL
Device Class
Class III
Advisory Committee
Clinical Chemistry
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PERIOCHECK Enzyme Activity Test Kit is an in vitro diagnostic device designed to measure periodontal enzyme activity. It is intended for use in clinical laboratory settings to assess biomarkers associated with periodontal disease.

Supplied as a test kit for single-use in vitro analysis, the device requires no sterilization and is not MRI conditional. It holds FDA PMA approval (P870059) and is classified under device class 3 as a Kit, Test, In Vitro Periodontal.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What type of test is the PERIOCHECK Enzyme Activity Test Kit?

    The PERIOCHECK Enzyme Activity Test Kit is an in vitro diagnostic test kit designed to measure periodontal enzyme activity, as specified in its generic name and device classification.

  • Is the PERIOCHECK test kit reusable or single-use?

    The device is supplied as a test kit for in vitro analysis and is intended for single-use, based on its classification as a diagnostic test kit with no indication of reusability in the provided data.

  • What regulatory authorization does the PERIOCHECK test kit have?

    The PERIOCHECK Enzyme Activity Test Kit has FDA PMA approval, with authorization number P870059, as stated in the AUTHORIZATIONS and pma_number fields.