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Massad MALB1IL1

by Cmp Industries LLC

Massad MALB1IL1 is a device of GMDN type resin artificial teeth (FDA Class II; FDA product code ELM, Denture, Plastic, Teeth) made by Cmp Industries LLC, cleared under FDA 510(k) K101029 on 16 Aug 2010 and listed in FDA GUDID since 26 Dec 2018 (UDI-DI M482MALB1IL10), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

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) K101029

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 NumberM482MALB1IL10 UDI-DI Date26 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101029 Date16 Aug 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101029 decided 16 Aug 2010 Active
  • FDA GUDID UDI-DI M482MALB1IL10 listed 26 Dec 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101029
  2. Listed FDA GUDID M482MALB1IL10

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Massad
Generic name
Resin artificial teeth
Model / Ref / Catalog
MALB1IL1
Primary DI / UDI-DI
M482MALB1IL10
510(k) Number
FDA product code
ELM
GMDN term
Resin artificial teeth
Device class
Class II
Regulation number
872.3590
GUDID distribution status
In Commercial Distribution

Related devices

Category: Resin artificial teeth

Cleared under the same submission (K101029)

and 8 more cleared under K101029

Similar devices

Other devices filed under FDA product code ELM (Denture, Plastic, Teeth).

Other devices from Cmp Industries LLC

  • Massad MPUD2I36U

    Class II

  • Nobilium 21142

    Class II

  • Nobilium NPUA3530U

    Class II

  • Massad MAUD2IO4

    Class II

See all devices from Cmp Industries LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)