Skip to content

Aira 600122

by Aira, LLC

Aira 600122 is a Class II device made by Aira, LLC, cleared under FDA 510(k) K230487 on 3 Jul 2023 and listed in FDA GUDID since 26 Aug 2026 (UDI-DI 00810194402128), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K230487

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810194402128 UDI-DI Date26 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230487 Date3 Jul 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230487 decided 3 Jul 2023 Active
  • FDA GUDID UDI-DI 00810194402128 listed 26 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230487
  2. Listed FDA GUDID 00810194402128

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aira
Generic name
Dental appliance fabrication material, ceramic
Model / reference
600122
Primary DI / UDI-DI
00810194402128
510(k) Number
FDA product code
EIH
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class II
Regulation number
872.6660
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EIH (Powder, Porcelain).

Other devices from Aira, LLC

  • Aira 119132

    Class I
  • Aira 119133

    Class I
  • Aira 119134

    Class I
  • Aira 119144

    Class I

See all devices from Aira, LLC →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)