FDA.reportPublic FDA data

Truform

Primary DI
00885797091925
Brand
Truform
Company
Rmo, Inc.
Model
B00606
Device description
MOLAR BAND MAX 14
Published
2024-08-20
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
00885797091925PrimaryGS10
00000008857972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797091925008857970919258857970919250885797091925
00000008857972000000088579720000088579720000008857972

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to 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
5
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
08033707035763LEONE SPALEONE SPAECM2020-11-11
08033707035770LEONE SPALEONE SPAECM2020-11-11
08033707035787LEONE SPALEONE SPAECM2020-11-11
08033707035794LEONE SPALEONE SPAECM2020-11-11
08033707035800LEONE SPALEONE SPAECM2020-11-11
08033707035817LEONE SPALEONE SPAECM2020-11-11
08033707035824LEONE SPALEONE SPAECM2020-11-11
08033707035831LEONE SPALEONE SPAECM2020-11-11
08033707035848LEONE SPALEONE SPAECM2020-11-11
08033707035855LEONE SPALEONE SPAECM2020-11-11
08033707035862LEONE SPALEONE SPAECM2020-11-11
08033707035879LEONE SPALEONE SPAECM2020-11-11
08033707035886LEONE SPALEONE SPAECM2020-11-11
08033707035893LEONE SPALEONE SPAECM2020-11-11
08033707035909LEONE SPALEONE SPAECM2020-11-11
08033707035916LEONE SPALEONE SPAECM2020-11-11
08033707035923LEONE SPALEONE SPAECM2020-11-11
08033707035930LEONE SPALEONE SPAECM2020-11-11
08033707035947LEONE SPALEONE SPAECM2020-11-11
08033707035954LEONE SPALEONE SPAECM2020-11-11
08033707035961LEONE SPALEONE SPAECM2020-11-11
08033707035978LEONE SPALEONE SPAECM2020-11-11
08033707035985LEONE SPALEONE SPAECM2020-11-11
08033707035992LEONE SPALEONE SPAECM2020-11-11
08033707036005LEONE SPALEONE SPAECM2020-11-11
08033707036012LEONE SPALEONE SPAECM2020-11-11
08033707036029LEONE SPALEONE SPAECM2020-11-11
08033707036036LEONE SPALEONE SPAECM2020-11-11