Skip to content

Henry Schein 5700348

by Henry Schein, Inc.

Henry Schein 5700348 is a device classified as Unclassified made by Henry Schein, Inc., cleared under FDA 510(k) K050180 on 11 Feb 2005 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10304040025960), 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) K050180

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 Number10304040025960 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050180 Date11 Feb 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050180 decided 11 Feb 2005 Active
  • FDA GUDID UDI-DI 10304040025960 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050180
  2. Listed FDA GUDID 10304040025960

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Henry Schein
Generic name
Gingival retraction kit
Model / Ref / Catalog
5700348
Primary DI / UDI-DI
10304040025960
510(k) Number
FDA product code
MVL
GMDN term
Gingival retraction kit
Device class
U
GUDID distribution status
In Commercial Distribution
Size
Weight — 1 Gram

Related devices

Category: Gingival retraction kit

Cleared under the same submission (K050180)

and 3 more cleared under K050180

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

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