FDA.reportPublic FDA data

TruForm

Primary DI
00885797100030
Brand
TruForm
Company
Rmo, Inc.
Model
K00564
Device description
MN 2MOL BD KT STD NO/L R&L 178
Published
2024-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ECMBand, Preformed, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885797100030PrimaryGS10
00000008857972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797100030008857971000308857971000300885797100030
00000008857972000000088579720000088579720000008857972

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.

Regulatory Flags#

DUNS number
007058183
Device count
178
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
00840456206225JMUJMU DENTAL, INCECM2026-06-25
00840456206232JMUJMU DENTAL, INCECM2026-06-25
08033707035015LEONE SPALEONE SPAECM2020-11-10
08033707035022LEONE SPALEONE SPAECM2020-11-10
08033707035039LEONE SPALEONE SPAECM2020-11-10
08033707035046LEONE SPALEONE SPAECM2020-11-10
08033707035053LEONE SPALEONE SPAECM2020-11-10
08033707035060LEONE SPALEONE SPAECM2020-11-10
08033707035077LEONE SPALEONE SPAECM2020-11-10
08033707035084LEONE SPALEONE SPAECM2020-11-10
08033707035091LEONE SPALEONE SPAECM2020-11-10
08033707035107LEONE SPALEONE SPAECM2020-11-10
08033707035114LEONE SPALEONE SPAECM2020-11-10
08033707035121LEONE SPALEONE SPAECM2020-11-10
08033707035138LEONE SPALEONE SPAECM2020-11-10
08033707035145LEONE SPALEONE SPAECM2020-11-10
08033707035152LEONE SPALEONE SPAECM2020-11-10
08033707035169LEONE SPALEONE SPAECM2020-11-10
08033707035176LEONE SPALEONE SPAECM2020-11-10
08033707035183LEONE SPALEONE SPAECM2020-11-10
08033707035190LEONE SPALEONE SPAECM2020-11-10
08033707035206LEONE SPALEONE SPAECM2020-11-10
08033707035213LEONE SPALEONE SPAECM2020-11-10
08033707035220LEONE SPALEONE SPAECM2020-11-10
08033707035237LEONE SPALEONE SPAECM2020-11-10
08033707035244LEONE SPALEONE SPAECM2020-11-10
08033707035251LEONE SPALEONE SPAECM2020-11-10
08033707035268LEONE SPALEONE SPAECM2020-11-10
08033707035275LEONE SPALEONE SPAECM2020-11-10
08033707035282LEONE SPALEONE SPAECM2020-11-10