Cleared Traditional

STATSTIX (K200764) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

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 35
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