FDA.reportPublic FDA data

RMO

Primary DI
00000008857972
Brand
RMO
Company
Rmo, Inc.
Model
FIDTL16
Device description
LINGUAL BUTTONS
Published
2024-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BRWProtector, Dental
DYHAdhesive, Bracket And Tooth Conditioner, Resin
DYJRetainer, Screw Expansion, Orthodontic
DYTMaintainer, Space Preformed, Orthodontic
DYWBracket, Plastic, Orthodontic
DZBHeadgear, Extraoral, Orthodontic
DZCWire, Orthodontic
DZDTube, Orthodontic
DZEImplant, Endosseous, Root-Form
DZNInstruments, Dental Hand
EBZActivator, Ultraviolet, For Polymerization
ECIBand, Elastic, Orthodontic
ECMBand, Preformed, Orthodontic
ECOSpring, Orthodontic
EHPClasp, Preformed
EHYTray, Impression, Preformed
EJFBracket, Metal, Orthodontic
KMYPositioner, Tooth, Preformed
KXRApplicator, Resin
NJMBracket, Ceramic, Orthodontic
ORTBurst Suppression Detection Software For Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2
DYJRetainer, Screw Expansion, OrthodonticDental1
DYTMaintainer, Space Preformed, OrthodonticDental1
DYWBracket, Plastic, OrthodonticDental2
DZBHeadgear, Extraoral, OrthodonticDental2
DZCWire, OrthodonticDental1
DZDTube, OrthodonticDental1
DZEImplant, Endosseous, Root-FormDental2
DZNInstruments, Dental HandDental1
EBZActivator, Ultraviolet, For PolymerizationDental2
ECIBand, Elastic, OrthodonticDental1
ECMBand, Preformed, OrthodonticDental1
ECOSpring, OrthodonticDental1
EHPClasp, PreformedDental1
EHYTray, Impression, PreformedDental1
EJFBracket, Metal, OrthodonticDental1
KMYPositioner, Tooth, PreformedDental1
KXRApplicator, ResinDental1
NJMBracket, Ceramic, OrthodonticDental2
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885797015556PrimaryGS10
00885797015587PrimaryGS10
00885797015594PrimaryGS10
00885797015600PrimaryGS10
00885797015617PrimaryGS10
00885797015624PrimaryGS10
00885797015631PrimaryGS10
00885797015648PrimaryGS10
00885797015662PrimaryGS10
00885797015679PrimaryGS10
00885797015686PrimaryGS10
00885797015693PrimaryGS10
00885797015716PrimaryGS10
00885797015723PrimaryGS10
00885797015914PrimaryGS10
00885797015921PrimaryGS10
00885797015938PrimaryGS10
00885797015945PrimaryGS10
00885797015952PrimaryGS10
00885797015969PrimaryGS10
00885797015976PrimaryGS10
00885797015983PrimaryGS10
00885797015990PrimaryGS10
00885797016003PrimaryGS10
00885797016010PrimaryGS10
00885797016034PrimaryGS10
00885797016041PrimaryGS10
00885797016058PrimaryGS10
00885797016072PrimaryGS10
00885797016089PrimaryGS10
00885797016096PrimaryGS10
00885797016119PrimaryGS10
00885797016126PrimaryGS10
00885797016133PrimaryGS10
00885797016140PrimaryGS10
00885797016157PrimaryGS10
00885797016164PrimaryGS10
00885797016171PrimaryGS10
00885797016188PrimaryGS10
00885797016195PrimaryGS10
00885797016201PrimaryGS10
00885797016218PrimaryGS10
00885797016225PrimaryGS10
00885797016232PrimaryGS10
00885797016256PrimaryGS10
00885797016263PrimaryGS10
00885797016270PrimaryGS10
00885797016294PrimaryGS10
00885797016300PrimaryGS10
00885797016317PrimaryGS10
00885797016331PrimaryGS10
00885797016348PrimaryGS10
00885797016355PrimaryGS10
00885797016362PrimaryGS10
00885797016379PrimaryGS10
00885797016386PrimaryGS10
00885797016393PrimaryGS10
00885797016409PrimaryGS10
00885797016416PrimaryGS10
00885797016423PrimaryGS10
00885797016430PrimaryGS10
00885797016447PrimaryGS10
00885797016454PrimaryGS10
00885797016461PrimaryGS10
00885797016478PrimaryGS10
00885797016492PrimaryGS10
00885797016515PrimaryGS10
00885797016539PrimaryGS10
00885797016553PrimaryGS10
00885797016577PrimaryGS10
00885797016591PrimaryGS10
00885797016614PrimaryGS10
00885797016638PrimaryGS10
00885797016652PrimaryGS10
00885797016676PrimaryGS10
00885797016690PrimaryGS10
00885797016713PrimaryGS10
00885797016737PrimaryGS10
00885797016751PrimaryGS10
00885797016768PrimaryGS10
00885797016775PrimaryGS10
00885797016782PrimaryGS10
00885797016799PrimaryGS10
00885797016805PrimaryGS10
00885797016812PrimaryGS10
00885797016829PrimaryGS10
00885797016836PrimaryGS10
00885797016843PrimaryGS10
00885797016850PrimaryGS10
00885797016867PrimaryGS10
00885797016874PrimaryGS10
00885797016881PrimaryGS10
00885797016898PrimaryGS10
00885797016904PrimaryGS10
00885797016911PrimaryGS10
00885797016928PrimaryGS10
00885797016935PrimaryGS10
00885797016942PrimaryGS10
00885797016959PrimaryGS10
00885797016966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797015556008857970155568857970155560885797015556
00885797015587008857970155878857970155870885797015587
00885797015594008857970155948857970155940885797015594
00885797015600008857970156008857970156000885797015600
00885797015617008857970156178857970156170885797015617
00885797015624008857970156248857970156240885797015624
00885797015631008857970156318857970156310885797015631
00885797015648008857970156488857970156480885797015648
00885797015662008857970156628857970156620885797015662
00885797015679008857970156798857970156790885797015679
00885797015686008857970156868857970156860885797015686
00885797015693008857970156938857970156930885797015693
00885797015716008857970157168857970157160885797015716
00885797015723008857970157238857970157230885797015723
00885797015914008857970159148857970159140885797015914
00885797015921008857970159218857970159210885797015921
00885797015938008857970159388857970159380885797015938
00885797015945008857970159458857970159450885797015945
00885797015952008857970159528857970159520885797015952
00885797015969008857970159698857970159690885797015969
00885797015976008857970159768857970159760885797015976
00885797015983008857970159838857970159830885797015983
00885797015990008857970159908857970159900885797015990
00885797016003008857970160038857970160030885797016003
00885797016010008857970160108857970160100885797016010
00885797016034008857970160348857970160340885797016034
00885797016041008857970160418857970160410885797016041
00885797016058008857970160588857970160580885797016058
00885797016072008857970160728857970160720885797016072
00885797016089008857970160898857970160890885797016089
00885797016096008857970160968857970160960885797016096
00885797016119008857970161198857970161190885797016119
00885797016126008857970161268857970161260885797016126
00885797016133008857970161338857970161330885797016133
00885797016140008857970161408857970161400885797016140
00885797016157008857970161578857970161570885797016157
00885797016164008857970161648857970161640885797016164
00885797016171008857970161718857970161710885797016171
00885797016188008857970161888857970161880885797016188
00885797016195008857970161958857970161950885797016195
00885797016201008857970162018857970162010885797016201
00885797016218008857970162188857970162180885797016218
00885797016225008857970162258857970162250885797016225
00885797016232008857970162328857970162320885797016232
00885797016256008857970162568857970162560885797016256
00885797016263008857970162638857970162630885797016263
00885797016270008857970162708857970162700885797016270
00885797016294008857970162948857970162940885797016294
00885797016300008857970163008857970163000885797016300
00885797016317008857970163178857970163170885797016317
00885797016331008857970163318857970163310885797016331
00885797016348008857970163488857970163480885797016348
00885797016355008857970163558857970163550885797016355
00885797016362008857970163628857970163620885797016362
00885797016379008857970163798857970163790885797016379
00885797016386008857970163868857970163860885797016386
00885797016393008857970163938857970163930885797016393
00885797016409008857970164098857970164090885797016409
00885797016416008857970164168857970164160885797016416
00885797016423008857970164238857970164230885797016423
00885797016430008857970164308857970164300885797016430
00885797016447008857970164478857970164470885797016447
00885797016454008857970164548857970164540885797016454
00885797016461008857970164618857970164610885797016461
00885797016478008857970164788857970164780885797016478
00885797016492008857970164928857970164920885797016492
00885797016515008857970165158857970165150885797016515
00885797016539008857970165398857970165390885797016539
00885797016553008857970165538857970165530885797016553
00885797016577008857970165778857970165770885797016577
00885797016591008857970165918857970165910885797016591
00885797016614008857970166148857970166140885797016614
00885797016638008857970166388857970166380885797016638
00885797016652008857970166528857970166520885797016652
00885797016676008857970166768857970166760885797016676
00885797016690008857970166908857970166900885797016690
00885797016713008857970167138857970167130885797016713
00885797016737008857970167378857970167370885797016737
00885797016751008857970167518857970167510885797016751
00885797016768008857970167688857970167680885797016768
00885797016775008857970167758857970167750885797016775
00885797016782008857970167828857970167820885797016782
00885797016799008857970167998857970167990885797016799
00885797016805008857970168058857970168050885797016805
00885797016812008857970168128857970168120885797016812
00885797016829008857970168298857970168290885797016829
00885797016836008857970168368857970168360885797016836
00885797016843008857970168438857970168430885797016843
00885797016850008857970168508857970168500885797016850
00885797016867008857970168678857970168670885797016867
00885797016874008857970168748857970168740885797016874
00885797016881008857970168818857970168810885797016881
00885797016898008857970168988857970168980885797016898
00885797016904008857970169048857970169040885797016904
00885797016911008857970169118857970169110885797016911
00885797016928008857970169288857970169280885797016928
00885797016935008857970169358857970169350885797016935
00885797016942008857970169428857970169420885797016942
00885797016959008857970169598857970169590885797016959
00885797016966008857970169668857970169660885797016966

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007058183
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885797644862TruLockJ040202024-08-23
00885797644879TruLockJ040212024-08-23
00885797664891TruLockJ040222024-08-23
00885797664907TruLockJ040232024-08-23
00885797664914TruLockJ040242024-08-23
00885797018403OrthonolA07408-12024-09-04
00885797526977FLI TwinM051502024-09-04
00885797019134ThermaloyA077102024-09-03
00885797099815TruFormK003292024-09-03
00885797099822TruFormK003302024-09-03
00885797099839TruFormK003312024-09-03
00885797099846TruFormK003322024-09-03
00885797099853TruFormK003332024-09-03
00885797099860TruFormK003342024-09-03
00885797099884RMOK004552024-09-03
00885797099891TruFormK005102024-09-03
00885797099907TruFormK005122024-09-03
00885797099914TruFormK005142024-09-03
00885797099921TruFormK005162024-09-03
00885797099938TruFormK005182024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000874Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
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07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049637Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16