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Ionosphere 1002153

by Henry Schein, Inc.

Ionosphere 1002153 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K821222 on 24 May 1982 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI H65810021531), active as of 23 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 23 Oct 2026

Documents

510(k) K821222

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberH65810021531 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK821222 Date24 May 1982DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K821222 decided 24 May 1982 Active
  • FDA GUDID UDI-DI H65810021531 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K821222
  2. Listed FDA GUDID H65810021531

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ionosphere
Generic name
Dental amalgam
Model / Ref / Catalog
1002153
Primary DI / UDI-DI
H65810021531
510(k) Number
FDA product code
EJJ
GMDN term
Dental amalgam
Device class
Class II
Regulation number
872.3070
GUDID distribution status
In Commercial Distribution
Size
Weight — 600 Milligram

Related devices

Category: Dental amalgam

Cleared under the same submission (K821222)

and 8 more cleared under K821222

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)