Pekkton Ivory

Material, Tooth Shade, Resin

CENDRES+METAUX SA

The following data is part of a premarket notification filed by Cendres+metaux Sa with the FDA for Pekkton Ivory.

Pre-market Notification Details

Device IDK170102
510k NumberK170102
Device Name:Pekkton Ivory
ClassificationMaterial, Tooth Shade, Resin
Applicant CENDRES+METAUX SA Rue De Boujean 122 Biel/bienne,  CH 2501
ContactUli Diermann
CorrespondentUli Diermann
CENDRES+METAUX SA Rue De Boujean 122 Biel/bienne,  CH 2501
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-11
Decision Date2017-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640166511526 K170102 000
07640166511502 K170102 000
07640166511496 K170102 000
07640166511489 K170102 000
07640166511472 K170102 000
07640166511458 K170102 000

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

A PHP Error was encountered

Severity: Core Warning

Message: Module 'zip' already loaded

Filename: Unknown

Line Number: 0

Backtrace: