Cleared Traditional

K210211 - PuraStat-OM (FDA 510(k) Clearance)

K210211 · 3-D Matrix, Inc. · General & Plastic Surgery device
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Oct 2021
Decision
254d
Days
-
Risk

K210211 is an FDA 510(k) clearance for the PuraStat-OM. Classified as Oral Wound Dressing (product code OLR).

Submitted by 3-D Matrix, Inc. (Newton, US). The FDA issued a Cleared decision on October 8, 2021 after a review of 254 days - an extended review cycle.

This device falls under the General & Plastic Surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all 3-D Matrix, Inc. devices

Submission Details

510(k) Number K210211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2021
Decision Date October 08, 2021
Days to Decision 254 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 114d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Consultant

Streamline Regulatory
Stephen P. Rhodes

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 - OLR Oral Wound Dressing

All 38
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