FDA.reportPublic FDA data

Biotech Dental

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107308763010730876Biotech Dental1Y2027-01-01145 Cedar Lane Suite 205 Englewood NJ US 07631

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
03701045220763KONTACT - I1-Scanbody for KW implant+1(866)277-5662info@biotechdentalusa.com
03701045220770KONTACT - I2-Scanbody for KW implant+1(866)277-5662info@biotechdentalusa.com
03701045220787KONTACT - I3-Scanbody for KW implant+1(866)277-5662info@biotechdentalusa.com
03701045220794KONTACT - I4-Scanbody for KW implant+1(866)277-5662info@biotechdentalusa.com
03701045220800KONTACT - I5-Scanbody for KW implant+1(866)277-5662info@biotechdentalusa.com
03701045220817KONTACT - I6-Scanbody for KW implant+1(866)277-5662info@biotechdentalusa.com
03701045279037KONTACT - I1-Short scanbody+1(866)277-5662info@biotechdentalusa.com
03701045279044KONTACT - I2-Short scanbody+1(866)277-5662info@biotechdentalusa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3004931972316856K213997Kontact Dental Implant SystemDZE2022-07-15
3004931309634400K212961SMILERSNXC2021-09-20
3004931178531394K210220Kontact Dental Implant SystemDZE2021-06-18
3004931430098170K180924Reflect Implant SystemDZE2019-03-29
3004931153893481
3004931249720307
3004931786557248
3004931906263944
3004932008839297

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE32022-07-15
NXC12021-09-20

GUDID#

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