FDA.reportPublic FDA data

TruLock

Primary DI
00885797664914
Brand
TruLock
Company
Rmo, Inc.
Model
J04024
Device description
TRULOCK Plastic Conditioner 15ml
Published
2024-08-23
Public version status
Update
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
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885797664914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797664914008857976649148857976649140885797664914

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007058183
Device count
1
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
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
00885797099945TruFormK005202024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998073557SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073564SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073571SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998062407SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062551SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062988SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062995SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063008SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063015SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063169SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063176SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063183SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063190SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063206SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063213SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063244SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063251SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063268SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063275SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063299SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063305SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063312SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063329SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063947SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063954SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063961SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063978SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063985SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063992SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998064005SolventumSolventum Orthodontics CorporationDYH2026-10-24