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NeoPEX™ Pre-Mixed Obturation Paste

by Nusmile, Ltd

510(k) K253909

NeoPEX Pre-Mixed Obturation Paste is a medical device (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Nusmile, Ltd, cleared under FDA 510(k) K253909 on 4 Sep 2026, active as of 25 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253909 Date4 Sep 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KIF
FDA applicant
NuSmile, Ltd.
Device class
Class II
Regulation
21 CFR Part 872.3820
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code KIF (Resin, Root Canal Filling).

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