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510(k) K210211

PuraStat-OM by 3-D Matrix, Inc. — Product Code OLR

K210211 is an FDA 510(k) premarket notification submitted by 3-D Matrix, Inc. for the device "PuraStat-OM". The FDA issued a decision of Substantially Equivalent on October 8, 2021. The device falls under product code OLR (Oral Wound Dressing), a Class U device. 3-D Matrix, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2021
Date Received
January 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oral Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Other clearances by 3-D Matrix, Inc.

  • K222481 — PuraStat (February 28, 2023)
  • K213552 — PuraStat-RM (April 1, 2022)
  • K210098 — PuraStat-GI (June 25, 2021)
  • K193085 — PuraDERM Gel (May 11, 2020)
  • K183015 — PuraSinus (April 12, 2019)
  • K143058 — PuraDerm Gel (February 13, 2015)

Other clearances for product code OLR

  • K260126 — Curajel™ Oral Gel (June 15, 2026)
  • K253816 — MuCover (proposed name) Oral Wound Dressing (May 21, 2026)
  • K253758 — Dental Cone; Dental Sponge (December 18, 2025)
  • K252425 — Silatrix Oral Gel (October 23, 2025)
  • K241283 — Elemental Granulate (January 3, 2025)
  • K230529 — HealiAid Dental Collagen Wound Dressing (November 22, 2023)
  • K221428 — PerioStom Dental Dressing (December 22, 2022)
  • K211851 — Ora-Aid (January 11, 2022)
  • K203091 — MucoLock Oral Gel (February 12, 2021)
  • K202000 — Silatrix Oral Gel (November 20, 2020)

FDA data resources