FDA PMA

Sealant, polymerizing

PMA Number: P010047 · 2026-03-12

ApplicantNeomend, Inc.

Decision Date2026-03-12

PMA NumberP010047

Product CodeNBE

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeAN

Device Summary

Sealant, polymerizing is the device name listed in this FDA 510(k) record. The listed applicant is Neomend, Inc.. It received FDA 510(k) clearance on 2026-03-12. The device is classified under product code NBE. It was reviewed by the AN advisory panel.

Frequently Asked Questions

What is the Sealant, polymerizing?

Sealant, polymerizing is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Neomend, Inc..

When did Sealant, polymerizing receive FDA 510(k) clearance?

The clearance date for Sealant, polymerizing can be found in the official FDA records.

Who is the listed applicant for Sealant, polymerizing?

The FDA 510(k) record lists Neomend, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sealant, polymerizing?

The FDA product code for Sealant, polymerizing is NBE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.