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Midmark DS-1200-001

by Midmark Corporation

Midmark DS-1200-001 is a Class I device made by Midmark Corporation, cleared under FDA 510(k) K251626 on 3 Nov 2025 and listed in FDA GUDID since 20 Feb 2026 (UDI-DI 00841709121869), 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) K251626

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 Number00841709121869 UDI-DI Date20 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251626 Date3 Nov 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251626 decided 3 Nov 2025 Active
  • FDA GUDID UDI-DI 00841709121869 listed 20 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251626
  2. Listed FDA GUDID 00841709121869

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Midmark
Generic name
Dental delivery system instrument unit, electric
Model / Ref / Catalog
DS-1200-001
Primary DI / UDI-DI
00841709121869
510(k) Number
FDA product code
EIA
GMDN term
Dental delivery system instrument unit, electric
Device class
Class I
Regulation number
872.6640
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code EIA (Unit, operative dental).

Other devices from Midmark Corporation

See all devices from Midmark Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)