AccuPlan System MC-KT001-H

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00810007631226 UDI-DI	Date1 Nov 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK223024	Date7 Mar 2023Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00810007631226
FDA 510(k) database 510(k) number K223024

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: AccuPlan System
Generic name: Dental milling system, CAD/CAM, laboratory
Model / Ref / Catalog: MC-KT001-H

Primary DI / UDI-DI: 00810007631226
510(k) Number: K223024
FDA product code: DZJ, LLZ
GMDN term: Dental milling system, CAD/CAM, laboratory

Device class: Class II
Regulation number: 872.4120, 892.2050
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Single use
Prescription use
Lot / batch number
Serial number

Other properties (10)

Supplied sterile: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Expiration date: No
Manufacturing date: No