Cleared Traditional

K200764 - STATSTIX

K200764 · Centrix Incorporated · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
205d
Days
-
Risk

K200764 is an FDA 510(k) clearance for the STATSTIX. Classified as Cord, Retraction (product code MVL).

Submitted by Centrix Incorporated (Shelton, US). The FDA issued a Cleared decision on October 15, 2020 after a review of 205 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Centrix Incorporated devices

FDA 510(k) Submission Details - K200764

510(k) Number K200764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2020
Decision Date October 15, 2020
Days to Decision 205 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 127d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Consultant

Medtek, LLC
Roger S Mastrony

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MVL Cord, Retraction

All 32
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K200764.
Stasis Gel
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Gingi-Aid Gel
K211419 · Belport Company, Inc., Gingi-Pak · Jan 2022
VOCO Retraction Paste
K213149 · Voco GmbH · Dec 2021
Vista Clear
K193389 · Inter-Med/Vista Dental Products · Mar 2020
Vista FS, Vista FS Liquid
K190220 · Inter-Med/Vista Dental Products · Jun 2019
Smartcord, Smartcord X
K171577 · Eastdent Co., Ltd. · May 2018