Ortho Pro Dent LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134106753013410675Ortho Pro Dent LLC1Y2026-01-011903 Northgate Blvd,Northogate Executive Center suite 114 Sarasota FL US 34234

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2042331031001420K112574PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENTEMA2012-01-23
2042331435000092K090567ORTHODONTIC CERAMIC BRACKETNJM2009-05-27
2042331786287527K022675PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIALEBF2002-11-07
2042331051651133K012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANTEBC2001-11-01
2042331698597864K012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEMDYH2001-10-24
2042331800135117K001108PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIALEBF2000-05-30
2042331009046748
2042331078305347
2042331111948833
2042331176681060
2042331396771445
2042331562694059
2042331562813319
2042331601327875
2042331781320176
2042331788953454
2042332043542966

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF22002-11-07
EMA12012-01-23
NJM12009-05-27
EBC12001-11-01
DYH12001-10-24

GUDID#

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