FDA.reportPublic FDA data

ZENTEK MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30171256933017125693ZENTEK MEDICAL LLC1N2026-01-0181 Pension Road Suite 116 Manalapan NJ US 07726

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
00850074346005Bonafix - Bonafix Two Implant 3.50 x 8mm Finished7329792502info@bonafixsdi.com
00850074346012Bonafix - Bonafix Two Implant 3.50 x 10mm Finished7329792502info@bonafixsdi.com
00850074346029Bonafix - Bonafix Two Implant 3.50 x 11.5mm Finished7329792502info@bonafixsdi.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2747551039089599K251294Bonafix Implant AbutmentsNHA2025-10-15
2747551638971123K221673Bonafix TiBaseNHA2023-07-14
2747551859179254K213677Bonafix 2 PlusDZE2022-12-20
2747551239668791K162853Bonafix TWO - Dental Implant SystemDZE2017-07-14
2747551891107480K122052MINIFIX BALL MINIFIX ONEDZE2012-11-28
2747551565078883K113650ORTHOFIX SCREWOAT2012-10-03
2747551608410325

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE32022-12-20
NHA22025-10-15
OAT12012-10-03

PMN#

GUDID#