NaturalLine Abutment

Abutment, Implant, Dental, Endosseous

OT MEDICAL GMBH

The following data is part of a premarket notification filed by Ot Medical Gmbh with the FDA for Naturalline Abutment.

Pre-market Notification Details

Device IDK151432
510k NumberK151432
Device Name:NaturalLine Abutment
ClassificationAbutment, Implant, Dental, Endosseous
Applicant OT MEDICAL GMBH KONSUL-SMIDT-STR. 8B Bremen,  DE D-28217
ContactMartina Behlau
CorrespondentMartina Behlau
OT MEDICAL GMBH KONSUL-SMIDT-STR. 8B Bremen,  DE D-28217
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-28
Decision Date2015-11-05

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