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Phoenix Elastics E-450-PD

by Phoenix Orthodontics Inc

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 23 Oct 2026. What this means

Overview

The Phoenix Elastics device is a non-sterile orthodontic inter-arch elastic band designed for single-use during orthodontic treatment. Its unique design features a continuous light force exerted across non-opposing mandibular and maxillary teeth, making it suitable for correcting malocclusions such as overbite and underbite. The device comes in patient packs of 100 and is marketed by Phoenix Orthodontics Inc., a company that has not received a label from the FDA for its products.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060772892383 UDI-DI Date17 Aug 2020ListedStatusListed 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  • Withdrawn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
Phoenix Elastics
Generic Name
Orthodontic inter-arch elastic band
Model / Ref / Catalog
E-450-PD
Primary DI / UDI-DI
05060772892383
FDA Product Code
ECI
GMDN Term
Orthodontic inter-arch elastic band
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
Not in Commercial Distribution

Properties

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

Other properties (8)

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