FDA 510(k) Application Details - K180183

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K180183
Device Name Implant, Endosseous, Root-Form
Applicant Ritter Implants GmbH & Co. KG
Gruner Weg 32
Biberach 88400 DE
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Contact Wemer Schmitz
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 01/23/2018
Decision Date 01/24/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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