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EdgeEndo EACTE70

by Hsg-S Corp

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810213813812 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EdgeEndo
Generic Name
Ultrasonic dental scaling/debridement system
Model / Reference
EACTE70
Primary DI / UDI-DI
00810213813812
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 (K053555)

Show all (12)

Other devices from Hsg-S Corp

See all devices from Hsg-S Corp →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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