RMO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17184761718476RMO1N2026-01-012165 Earlywood Drive Franklin IN US 46131
30309705803030970580RMO1N2026-01-0119, Jalan Firma 1/5, Kawasan Perindustrian Tebrau 1 Johor Bahru MY 81100

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2815371959212761K993224T-GEAR, MODEL TG/400-700DZB2000-02-11
2815371344631273K963205ALGINMAX, ORTHOCHROMEELW1996-10-29
2815371306703668K950121FRANCE ORTHODONTIEDZB1995-03-08
2815371238742565K182672ROSA BracketNJM2019-11-15
2815371270673004K120471MACH BRACKETS BRIGHT BRACKETSNJM2012-06-04
2815371488742235K072830RM BOND, MODEL J032DYH2007-12-04
2815371220967477K052370CP BRACKET SYSTEMDYW2005-11-01
2815371197208930K033767DUAL TOP ANCHOR SYSTEM SCREWSDZE2004-02-24
2815371314613804K030743ETCHANT 40%KLE2003-05-09
2815371964209499K002991ZAP DUAL CURING LIGHTEBZ2000-11-28
2815371007029978
2815371029120987
3280161033221944
2815371034839670
2815371050251046
2815371077475920
3280161098933778
3280161102885368
2815371120686201
3280161138158284
2815371151844902
2815371191048390
3280161195330398
2815371211611745
2815371216824867
2815371236352208
3280161245881609
2815371254268537
2815371285503132
3280161288363342
2815371308124106
2815371334650787
3280161336250306
3280161397150670
2815371412335877
3280161426415699
3280161450117624
2815371452382708
3280161475280107
2815371481770477
2815371485381750
3280161519521336
2815371744025918
2815371748060332
2815371757617630
2815371776920091
3280161870115846
2815371942241556
3280162033285655
2815372040027598
2815372047723446
3280162056652443

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NJM22019-11-15
DZB22000-02-11
DYH12007-12-04
DYW12005-11-01
DZE12004-02-24
KLE12003-05-09
EBZ12000-11-28
ELW11996-10-29