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Shofu Block HC 2159B

by Shofu Dental Corp.

Shofu Block HC 2159B is a dental milling system (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Shofu Dental Corp., listed in FDA GUDID since 23 Sep 2016 (UDI-DI E2352159B9), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberE2352159B9 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Shofu Block HC
Generic name
Dental milling system, CAD/CAM, chairside
Model / Ref / Catalog
2159B
Primary DI / UDI-DI
E2352159B9
FDA product code
EBF
GMDN term
Dental milling system, CAD/CAM, chairside
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EBF (Material, Tooth Shade, Resin).

Other devices from Shofu Dental Corp.

See all devices from Shofu Dental Corp. →

Properties

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