510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nobel Biocare c/o Medicim NV

Mechelen Antwerpen, BE

Nobel Biocare c/o Medicim NV appears in FDA device records in Mechelen Antwerpen, BE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. 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
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Nobel Biocare c/o Medicim NV in 2025.

Clearances by year, as a table
510(k) clearance decisions for Nobel Biocare c/o Medicim NV, by decision year
YearClearances
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252086DTX Studio AssistMYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Nobel Biocare c/o Medicim NV, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30057396553005739655Nobel Biocare c/o Medicim NVStationsstraat 102, Mechelen Antwerpen B-2800 BE2026

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

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