Skip to content

SM3 S200EL

by Osstem Implant Co., Ltd._Gasan Branch

SM3 S200EL is a Class II device made by Osstem Implant Co., Ltd._Gasan Branch, listed in FDA GUDID since 25 Apr 2019 (UDI-DI 08800000995229), 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 Number08800000995229 UDI-DI Date25 Apr 2019ListedStatusListed 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  • Withdrawn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
SM3
Generic name
Dental power tool system handpiece, line-powered
Model / reference
S200EL
Primary DI / UDI-DI
08800000995229
FDA product code
KMW, EGS, EBW
GMDN term
Dental power tool system handpiece, line-powered
Device class
Class II
Regulation number
872.4120, 872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental power tool system handpiece, line-powered

Similar devices

Other devices filed under FDA product code KMW (Handpiece, Rotary Bone Cutting).

Other devices from Osstem Implant Co., Ltd._Gasan Branch

Properties

  • Sterilise before use
  • Serial number
Other properties (13, all answered No)