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Heliosit 532629AN

by Ivoclar Vivadent Aktiengesellschaft

Listed FDA GUDID listing, not in commercial distribution

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 NumberDVIV532629AN1 UDI-DI Date12 Dec 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Heliosit
Generic Name
Orthodontic bracket adhesive
Model / Ref / Catalog
532629AN
Primary DI / UDI-DI
DVIV532629AN1
FDA Product Code
DYH
GMDN Term
Orthodontic bracket adhesive
Device Class
Class II
Regulation Number
872.3750
GUDID distribution status
Not in Commercial Distribution

Other devices from Ivoclar Vivadent Aktiengesellschaft

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: 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