FDA.reportPublic FDA data

CeramTec Schweiz GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30083882483008388248CeramTec Schweiz GmbH1N2026-01-01Bodenaeckerstrasse 5 Spreitenbach Aargau CH 8957

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07640161394322NobelPearl Tapered NP 3.5x8mm - Dental Implant+41443883636mpd.regulatory@ceramtec.de
07640161394339NobelPearl Tapered NP 3.5x10mm - Dental Implant+41443883636mpd.regulatory@ceramtec.de
07640161394346NobelPearl Tapered NP 3.5x12mm - Dental Implant+41443883636mpd.regulatory@ceramtec.de
07640161394599NobelPearl™ Abutment Straight Inter-X NP 1mm - Prosthetics+41443883636mpd.regulatory@ceramtec.de
07640161394629NobelPearl™ Cover Screw Inter-X NP - Prosthetics+41443883636mpd.regulatory@ceramtec.de
07640161394636NobelPearl™ Healing Abutment Inter-X NP 3.5x3mm - Prosthetics+41443883636mpd.regulatory@ceramtec.de
07640161394643NobelPearl™ Healing Abutment Inter-X NP 3.5x4mm - Prosthetics+41443883636mpd.regulatory@ceramtec.de
07640161394650NobelPearl™ Temporary Abutment Inter-X NP - Prosthetics+41443883636mpd.regulatory@ceramtec.de

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1168331811402213K180184Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant SystemNHA2018-11-16
1168331571732328K163043Zeramex P6 Dental Implant SystemDZE2016-11-30
1168331984791244K152385Zeramex P6 Dental Implant SystemDZE2016-07-27
1168331650868174
1168331685363586
1168331114157003

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE42016-11-30
NHA22018-11-16

GUDID#

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