MK-dent ACCESSORIES

by MK-Dent GmbH 19 variants

MK-dent ACCESSORIES (AM0002) is a Class I device made by MK-Dent GmbH, cleared under FDA 510(k) K051872 on 3 Oct 2005 and listed in FDA GUDID since 14 Oct 2024 (UDI-DI E490AM00021), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberE490AM00021 UDI-DI	Date14 Oct 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK051872	Date3 Oct 2005Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K051872

Across registries

2 registries list this device

FDA 510(k) K051872 decided 3 Oct 2005 Active
FDA GUDID UDI-DI E490AM00021 listed 14 Oct 2024 Listed

Timeline

2 dated events

3 Oct 2005 Cleared FDA 510(k) K051872
14 Oct 2024 Listed FDA GUDID E490AM00021

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: MK-dent
Generic name: Dental surgical power tool motor, pneumatic
Model / Ref / Catalog: ACCESSORIES, AM0002

Primary DI / UDI-DI: E490AM00021
510(k) Number: K051872
FDA product code: EFB
GMDN term: Dental surgical power tool motor, pneumatic

Device class: Class I
Regulation number: 872.4200
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Dental surgical power tool motor, pneumatic.

Other devices from MK-Dent GmbH

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Coupling

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Contra Angle Head

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See all devices from MK-Dent GmbH →

Properties

Over-the-counter
Serial number
Manufacturing date

Other properties (12, all answered No)