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Ortho Pro X1-115

by Ortho Pro Dent LLC

Ortho Pro X1-115 is a Class I device made by Ortho Pro Dent LLC, listed in FDA GUDID since 6 Nov 2024 (UDI-DI 00810152826553), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810152826553 UDI-DI Date6 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ortho Pro
Generic name
Orthodontic inter-arch elastic band
Model / reference
X1-115
Description
Facebows size #1 ,lingual arch 115 mm, length 83 mm extra short
Primary DI / UDI-DI
00810152826553
FDA product code
ECI
GMDN term
Orthodontic inter-arch elastic band
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ECI (Band, Elastic, Orthodontic).

Other devices from Ortho Pro Dent LLC

See all devices from Ortho Pro Dent LLC →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (10, all answered No)