FDA.report

AXIODENT INC.

Matched from indexed company URL: Axiodent Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30323125613032312561AXIODENT INC.1Y2026-01-01501 Silverside Rd Ste 105 # 5086 Wilmington DE US 19809

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3313111466524966K233273C&B Ceramic; C&B Permanent; C&B InterimEBF2024-11-27
3313112059101863K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalKLE2023-08-11
3313111549268095K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTEBF2024-01-05
3313111957716932K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)ELW2022-09-09
3313111787201632K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/LiquidKIF2022-05-23
3313111257747469K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)EJK2022-05-13
3313111642552611K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)EMA2021-05-13
3313111005098877
3313111167085820
3313111531709296
3313111626011691
3313111774237721

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
EBF22024-11-27
KLE12023-08-11
ELW12022-09-09
KIF12022-05-23
EJK12022-05-13
EMA12021-05-13

GUDID

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