510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210211Substantially Equivalent

PuraStat-OM

3-D Matrix, Inc., Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210211 is the FDA 510(k) clearance record for PuraStat-OM, cleared for 3-D Matrix, Inc. on under FDA product code OLR (Oral Wound Dressing). FDA's definition for product code OLR reads: "Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ". FDA records list 9 510(k) clearances for 3-D Matrix, Inc., from to . As of , FDA records show no recalls naming K210211.

Clearance record

Decision date
Received
(254 days to decision)
Product code
OLR Oral Wound Dressing
Device class
Unclassified
Review panel
Unknown
Applicant
3-D Matrix, Inc. 1234 Chestnut St., Suite 205, Newton MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLR

Trailing 12 months
5 clearances under product code OLR in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLR, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20261
August 20261
September 20260
October 20260