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GBT Machine AIRFLOW Prophylaxis Master FT-300

by E.M.S. Electro Medical Systems S.A. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613353347802 UDI-DI Date16 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GBT Machine AIRFLOW Prophylaxis Master
Generic Name
Ultrasonic dental scaling/debridement system
Model / Ref / Catalog
FT-300, FT-300 2B 302
Primary DI / UDI-DI
07613353347802
510(k) Number
FDA Product Code
ELC
GMDN Term
Ultrasonic dental scaling/debridement system
Device Class
Class II
Regulation Number
872.4850
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K253254)

Show all (12)

Other devices from Electro Medical Systems (Ems Sa)

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Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No