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Eagle Spectrum 001-942

by American Orthodontics United States GUDID

Product code DYH

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190746061394 UDI-DIDate10 Apr 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
Eagle Spectrum
Generic Name
Orthodontic bracket adhesive
Model / Ref / Catalog
001-942
Primary DI / UDI-DI
00190746061394
510(k) Number
FDA Product Code
DYH
GMDN Term
Orthodontic bracket adhesive
Device Class
Class II
Regulation Number
872.3750
Commercial Distribution
In Commercial Distribution

Related devices

Cleared under the same submission (K831495)

Show all (12)

Other devices from American Orthodontics

See all devices from American Orthodontics →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Expiration 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
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 28178606-4b11-4de5-91fe-a0bb1cbd08b7 37 fields · synced 23 Oct 2026