FDA.reportPublic FDA data

RMO

Primary DI
00885797672292
Brand
RMO
Company
Rmo, Inc.
Model
A00788
Device description
Mouthguard Braces Bubblegum
Published
2024-08-26
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885797672292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797672292008857976722928857976722920885797672292

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007058183
Device count
1
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
00885797099730RMOK002502024-09-03
00885797099747RMOK0025022024-09-03
00885797099754RMOK002532024-09-03
008857971002453DK008502024-09-03
008857971002763DK009302024-09-03
00885797098566RMOA070752024-09-02
00885797098870RMOA007882024-09-02
00885797098900RMOJ007702024-09-02
00885797098917RMOJ007712024-09-02
00885797098924RMOJ00771-12024-09-02
00885797099549RMOK000052024-09-02
00885797523693SchweickhardtA041592024-09-02
00885797652812Mini TwinKM134022024-09-02
00885797674265TruLockJ040032024-09-02
00885797674272TruLockJ040052024-09-02
00885797692184Mini TwinKM135002024-09-02
00885797692191Mini TwinKM135022024-09-02
00885797692207Mini TwinKM135502024-09-02
00885797692214Mini TwinKM135522024-09-02
00885797695277Alpine SLKM221022024-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017902302EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017900605EZ Bite blockDXM CO., LTDBRW2025-12-16
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.BRW2025-08-01
08800142100949Tera Harz GuardGraphy Inc.BRW2025-07-18
00885797672278RMORmo, Inc.BRW2024-08-26
00000008857972RMORmo, Inc.BRW2024-08-12
10889483007563SunMedSUNMED, LLCBRW2024-03-12
08800075604170OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604187OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604194OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
10630094199709Bioseal Inc.BIOSEALBRW2023-12-12
10630094199204Bioseal Inc.BIOSEALBRW2023-12-11
10630094199259Bioseal Inc.BIOSEALBRW2023-12-11
10630094199303Bioseal Inc.BIOSEALBRW2023-12-11
10630094199327Bioseal Inc.BIOSEALBRW2023-12-11
10630094199013Bioseal Inc.BIOSEALBRW2023-12-07
10630094199112Bioseal Inc.BIOSEALBRW2023-12-07
10630094199129Bioseal Inc.BIOSEALBRW2023-12-07
10630094199136Bioseal Inc.BIOSEALBRW2023-12-07
08800017900599EZ Bite blockDXM CO., LTDBRW2023-07-26
10889483231135SunMedSUNMED, LLCBRW2023-07-18
00723896020210FlexiProp Reusable Mouth Prop 2 PK Small PRACTICON, INC.BRW2023-06-08
00723896020241FlexiProp Reusable Mouth Prop 2 PK Medium PRACTICON, INC.BRW2023-06-08
00723896020272FlexiProp Reusable Mouth Prop 2 PK LargePRACTICON, INC.BRW2023-06-08
M63342818520JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-09
M63342818530JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-09
M63342818500JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-03
M63342818510JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-02-24
D72310297450Safco Mouth PropsSAFCO DENTAL SUPPLY CO.BRW2022-11-30