Dental Implant OKTAGON Bone Level

Implant, Endosseous, Root-form

Hager & Meisinger GmbH

The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Dental Implant Oktagon Bone Level.

Pre-market Notification Details

Device IDK143539
510k NumberK143539
Device Name:Dental Implant OKTAGON Bone Level
ClassificationImplant, Endosseous, Root-form
Applicant Hager & Meisinger GmbH Hansemannstrasse 10 Neuss,  DE 41468
ContactWiebke Stolten
CorrespondentWiebke Stolten
Hager & Meisinger GmbH Hansemannstrasse 10 Neuss,  DE 41468
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-15
Decision Date2015-08-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E0HM221101 K143539 000
E0HM50220231 K143539 000
E0HM50220241 K143539 000
E0HM50220271 K143539 000
E0HM50220281 K143539 000
E0HM50220291 K143539 000
E0HM50221061 K143539 000
E0HM50221071 K143539 000
E0HM50221081 K143539 000
E0HM50221091 K143539 000
E0HM221281 K143539 000
E0HM221271 K143539 000
E0HM221261 K143539 000
E0HM221151 K143539 000
E0HM221161 K143539 000
E0HM221171 K143539 000
E0HM221181 K143539 000
E0HM221191 K143539 000
E0HM221201 K143539 000
E0HM221221 K143539 000
E0HM221241 K143539 000
E0HM221251 K143539 000
E0HM50221101 K143539 000
E0HM50221151 K143539 000
EDRS220131 K143539 000
EDRS220141 K143539 000
EDRS220171 K143539 000
EDRS220181 K143539 000
EDRS220191 K143539 000
EDRS220201 K143539 000
EDRS220211 K143539 000
EDRS220221 K143539 000
EDRS220231 K143539 000
EDRS220121 K143539 000
EDRS220111 K143539 000
EDRS220101 K143539 000
EDRS220011 K143539 000
EDRS220021 K143539 000
EDRS220031 K143539 000
EDRS220041 K143539 000
EDRS220051 K143539 000
EDRS220061 K143539 000
EDRS220071 K143539 000
EDRS220081 K143539 000
EDRS220091 K143539 000
EDRS220241 K143539 000
E0HM221091 K143539 000
E0HM220011 K143539 000
E0HM220141 K143539 000
E0HM220171 K143539 000
E0HM220181 K143539 000
E0HM220191 K143539 000
E0HM220201 K143539 000
E0HM220211 K143539 000
E0HM220221 K143539 000
E0HM220231 K143539 000
E0HM220241 K143539 000
E0HM220131 K143539 000
E0HM220121 K143539 000
E0HM220111 K143539 000
E0HM220021 K143539 000
E0HM220031 K143539 000
E0HM220041 K143539 000
E0HM220051 K143539 000
E0HM220061 K143539 000
E0HM220071 K143539 000
E0HM220081 K143539 000
E0HM220091 K143539 000
E0HM220101 K143539 000
E0HM220271 K143539 000
E0HM220281 K143539 000
E0HM220911 K143539 000
E0HM220921 K143539 000
E0HM220931 K143539 000
E0HM220941 K143539 000
E0HM220951 K143539 000
E0HM220981 K143539 000
E0HM220991 K143539 000
E0HM221061 K143539 000
E0HM221071 K143539 000
E0HM220901 K143539 000
E0HM220431 K143539 000
E0HM220391 K143539 000
E0HM220291 K143539 000
E0HM220301 K143539 000
E0HM220321 K143539 000
E0HM220331 K143539 000
E0HM220341 K143539 000
E0HM220351 K143539 000
E0HM220361 K143539 000
E0HM220371 K143539 000
E0HM220381 K143539 000
E0HM221081 K143539 000
E0HM50220171 K143539 000
E0HM50220381 K143539 000
E0HM50220391 K143539 000
E0HM50220431 K143539 000
E0HM50220901 K143539 000
E0HM50220911 K143539 000
E0HM50220921 K143539 000
E0HM50220931 K143539 000
E0HM50220941 K143539 000
E0HM50220951 K143539 000
E0HM50220371 K143539 000
E0HM50220361 K143539 000
E0HM50220351 K143539 000
E0HM50220181 K143539 000
E0HM50220191 K143539 000
E0HM50220201 K143539 000
E0HM50220211 K143539 000
E0HM50220221 K143539 000
E0HM50220301 K143539 000
E0HM50220321 K143539 000
E0HM50220331 K143539 000
E0HM50220341 K143539 000
E0HM50221161 K143539 000
E0HM50221171 K143539 000
E0HM503312BL1 K143539 000
E0HM503314BL1 K143539 000
E0HM504108BL1 K143539 000
E0HM504110BL1 K143539 000
E0HM504112BL1 K143539 000
E0HM504114BL1 K143539 000
E0HM504808BL1 K143539 000
E0HM504810BL1 K143539 000
E0HM504812BL1 K143539 000
E0HM503310BL1 K143539 000
E0HM503308BL1 K143539 000
E0HM50221281 K143539 000
E0HM50221181 K143539 000
E0HM50221191 K143539 000
E0HM50221201 K143539 000
E0HM50221221 K143539 000
E0HM50221231 K143539 000
E0HM50221241 K143539 000
E0HM50221251 K143539 000
E0HM50221261 K143539 000
E0HM50221271 K143539 000
E0HM504814BL1 K143539 000
XXXX50221229 K143539 000
EDRS220271 K143539 000
EDRS220901 K143539 000
EDRS220911 K143539 000
EDRS220921 K143539 000
EDRS220931 K143539 000
EDRS220941 K143539 000
EDRS220951 K143539 000
EDRS220981 K143539 000
EDRS220991 K143539 000
EDRS221061 K143539 000
EDRS220431 K143539 000
EDRS220391 K143539 000
EDRS220381 K143539 000
EDRS220281 K143539 000
EDRS220291 K143539 000
EDRS220301 K143539 000
EDRS220321 K143539 000
EDRS220331 K143539 000
EDRS220341 K143539 000
EDRS220351 K143539 000
EDRS220361 K143539 000
EDRS220371 K143539 000
EDRS221071 K143539 000
EDRS221081 K143539 000
EDRS221261 K143539 000
EDRS221271 K143539 000
EDRS221281 K143539 000
XXXX50220399 K143539 000
XXXX50221069 K143539 000
XXXX50221079 K143539 000
XXXX50221089 K143539 000
XXXX50221169 K143539 000
XXXX50221179 K143539 000
EDRS221251 K143539 000
EDRS221241 K143539 000
EDRS221231 K143539 000
EDRS221091 K143539 000
EDRS221101 K143539 000
EDRS221151 K143539 000
EDRS221161 K143539 000
EDRS221171 K143539 000
EDRS221181 K143539 000
EDRS221191 K143539 000
EDRS221201 K143539 000
EDRS221221 K143539 000
XXXX50221199 K143539 000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.