MEDENTiKA OT 8501

by MEDENTiKA GmbH

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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04251574845382 UDI-DI	Date1 May 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK223113	Date15 Apr 2024Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: MEDENTiKA
Generic name: Dental prosthesis/implant abutment screw
Model / Ref / Catalog: OT 8501

Primary DI / UDI-DI: 04251574845382
510(k) Number: K223113
FDA product code: NHA
GMDN term: Dental prosthesis/implant abutment screw

Device class: Class II
Regulation number: 872.3630
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization
MRI safety: MR Conditional

Other devices from MEDENTiKA GmbH

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Class I
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Class I
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Class IIa
MEDENTiKA

Class I

See all devices from MEDENTiKA GmbH →

Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number
Manufacturing date

Other properties (9)

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