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Hexa HE-1050

by Hexa Dental 2 variants

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

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 Number00850057092196 UDI-DI Date12 Jan 2026ListedStatusListed 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  • Withdrawn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
Hexa
Generic Name
Dental tooth-etching solution
Model / Reference
HE-1050
Description
Hexa Etch Gel 37% , 50ml , 4/1.2ml Syringes Blue JUMBO, HE-1050 + 50 pre bent tips
Primary DI / UDI-DI
00850057092196
FDA Product Code
EBF
GMDN Term
Dental tooth-etching solution
Device Class
Class II
Regulation Number
872.3690
GUDID distribution status
In Commercial Distribution

Other devices from Hexa Dental

See all devices from Hexa Dental →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No