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Nivo NB2729

by B. Ali Impex

Nivo NB2729 is a manual dental burnisher (FDA Class I; FDA product code EKJ, Burnisher, Operative) made by B. Ali Impex, listed in FDA GUDID since 27 Jan 2024 (UDI-DI 08964003163303), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08964003163303 UDI-DI Date27 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Nivo
Generic name
Manual dental burnisher, reusable
Model / reference
NB2729
Primary DI / UDI-DI
08964003163303
FDA product code
EKJ
GMDN term
Manual dental burnisher, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual dental burnisher, reusable

Similar devices

Other devices filed under FDA product code EKJ (Burnisher, Operative).

Other devices from B. Ali Impex

See all devices from B. Ali Impex →

Properties

  • Sterilise before use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)