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Defend SP-9900

by Young Mydent, LLC

Defend SP-9900 is a Class II device made by Young Mydent, LLC, cleared under FDA 510(k) K143637 on 9 Sep 2015 and listed in FDA GUDID since 1 Sep 2017 (UDI-DI 00816577022617), 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) K143637

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 Number00816577022617 UDI-DI Date1 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143637 Date9 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143637 decided 9 Sep 2015 Active
  • FDA GUDID UDI-DI 00816577022617 listed 1 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K143637
  2. Listed FDA GUDID 00816577022617

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Defend
Generic name
Sterilization packaging, single-use
Model / Ref / Catalog
SP-9900
Primary DI / UDI-DI
00816577022617
510(k) Number
FDA product code
FRG
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K143637)

and 8 more cleared under K143637

Other devices from Young Mydent, LLC

See all devices from Young Mydent, LLC →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)