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Otto Leibinger AESRLAN3

by American Eagle Instruments

Otto Leibinger AESRLAN3 is a Class I device made by American Eagle Instruments, listed in FDA GUDID since 6 Jan 2026 (UDI-DI 00841013120664), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841013120664 UDI-DI Date6 Jan 2026ListedStatusListed 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  • Withdrawn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
Otto Leibinger
Generic name
Dental cheek retractor, professional, reusable
Model / reference
AESRLAN3
Primary DI / UDI-DI
00841013120664
FDA product code
GAD
GMDN term
Dental cheek retractor, professional, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code GAD (Retractor).

Other devices from American Eagle Instruments

See all devices from American Eagle Instruments →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)