# 3-D Matrix, Inc.

- Location (FDA's records): Newton, MA
- FDA decisions: 9 (2015–2026): 9 510(k) clearances
- Product codes: QAU (3), PHN (2), FRO (2), OLR (1), NHB (1)
- Predicates its devices cite: 14 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3-D Matrix Europe SAS: 4 (https://510kreport.com/company/3-d-matrix-europe)
- Coloplast Corp.: 2 (https://510kreport.com/company/coloplast)
- Merlin Group Dba Mcmerlin Dental Company: 1 (https://510kreport.com/company/merlin-group-dba-mcmerlin-dental)
- Access Pharmaceuticals, Inc.: 1 (https://510kreport.com/company/access-pharmaceuticals)
- Convatec, A Bristol-Myers Squibb Co.: 1 (https://510kreport.com/company/convatec-a-bristol-myers-squibb)
- Wilson-Cook Medical, Inc.: 1 (https://510kreport.com/company/wilson-cook-medical)

## Firms that cite its devices most
- 3-D Matrix Europe SAS: 2 (https://510kreport.com/company/3-d-matrix-europe)
- Arch Therapeutics, Inc.: 1 (https://510kreport.com/company/arch-therapeutics)

## Its most-cited devices
- K213552: PuraStat-RM (2022), cited by 2
- K143058: PuraDerm Gel (2015), cited by 2
- K222481: PuraStat (2023), cited by 1
- K210211: PuraStat-OM (2021), cited by 1
- K210098: PuraStat-GI (2021), cited by 1

## Recent decisions
- K261504: PuraStat-RM (Aug 3, 2026)
- K261503: PuraStat GI (Aug 3, 2026)
- K222481: PuraStat (Feb 28, 2023)
- K213552: PuraStat-RM (Apr 1, 2022)
- K210211: PuraStat-OM (Oct 8, 2021)
- K210098: PuraStat-GI (Jun 25, 2021)
- K193085: PuraDERM Gel (May 11, 2020)
- K183015: PuraSinus (Apr 12, 2019)

Source page: https://510kreport.com/company/3-d-matrix