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NeoMTA Plus MN250

by Avalon Biomed Inc.

NeoMTA Plus MN250, an endodontic filling/sealing material (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Avalon Biomed Inc., was cleared under FDA 510(k) K140955 on 11 Jun 2014 and listed in FDA GUDID on 19 Dec 2017 (UDI-DI 08575700061252); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K140955

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08575700061252 UDI-DI Date19 Dec 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK140955 Date11 Jun 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140955 decided 11 Jun 2014 Active
  • FDA GUDID UDI-DI 08575700061252 listed 19 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140955
  2. Listed FDA GUDID 08575700061252

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NeoMTA Plus
Generic name
Endodontic filling/sealing material
Model / reference
MN250
Primary DI / UDI-DI
08575700061252
510(k) Number
FDA product code
KIF
GMDN term
Endodontic filling/sealing material
Device class
Class II
Regulation number
872.3820
GUDID distribution status
Not in Commercial Distribution
Size
Weight — 2.5 Gram

Similar devices

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

Other devices from Avalon Biomed Inc.

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)