510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medentika GmbH

Huegelsheim Baden-Wurttemberg, DE

MEDENTIKA GMBH appears in FDA device records in Huegelsheim Baden-Wurttemberg, DE. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 10 510(k) clearances for Medentika GmbH between 2015 and 2025. The busiest year on record is 2020, with 3. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Medentika GmbH, by decision year
YearClearances
20152
20171
20191
20203
20241
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253341Custom Abutments ASNHASubstantially Equivalent
K242542Medentika CAD/CAM AbutmentsNHASubstantially Equivalent
K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsNHASubstantially Equivalent
K201711CARES Screw - Retained Bars and Bridges (SRBB)NHASubstantially Equivalent
K200906MINICONE ImplantDZESubstantially Equivalent
K191123Multi-unit AbutmentsNHASubstantially Equivalent
K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesNHASubstantially Equivalent
K170838Medentika CAD/CAM TiBasesNHASubstantially Equivalent
K150203Medentika CAD/CAM AbutmentsNHASubstantially Equivalent
K142167MEDENTIKA ABUTMENT SYSTEMNHASubstantially Equivalent

Registered establishments

FDA registered establishments for Medentika GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087706463008770646MEDENTIKA GMBHHammweg 8-10, Huegelsheim Baden-Wurttemberg 76549 DE2026
30264441993026444199Medentika GmbHIm Interkom 32, Calw Baden-Wurttemberg 75365 DE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain