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Stratosphere 1005748

by Henry Schein, Inc.

Stratosphere 1005748 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K820617 on 25 Mar 1982 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI H65810057481), 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) K820617

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 NumberH65810057481 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK820617 Date25 Mar 1982DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K820617 decided 25 Mar 1982 Active
  • FDA GUDID UDI-DI H65810057481 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K820617
  2. Listed FDA GUDID H65810057481

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stratosphere
Generic name
Dental amalgam
Model / Ref / Catalog
1005748
Primary DI / UDI-DI
H65810057481
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 — 400 Milligram

Related devices

Category: Dental amalgam

Cleared under the same submission (K820617)

and 8 more cleared under K820617

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)