FDA.reportPublic FDA data

TBS BASICS

Primary DI
G149TBSB1270
Brand
TBS BASICS
Company
ACME ENTERPRISE.
Model
TBSB127
Catalog number
TBSB127
Device description
TBS BASICS Bracket Height Positioning Gauge
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EILGauge, Depth, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G149TBSB1270PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance dimension gaugeA dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645459892
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G149TBSB71000TBS BASICSTBSB7100TBSB71002026-05-22
G149TBSB71010TBS BASICSTBSB7101TBSB71012026-05-22
G149TBSB71020TBS BASICSTBSB7102TBSB71022026-05-22
G149TBSB71030TBS BASICSTBSB7103TBSB71032026-05-22
G149TBSB71040TBS BASICSTBSB7104TBSB71042026-05-22
G149TBSB71050TBS BASICSTBSB7105TBSB71052026-05-22
G149TBSB71060TBS BASICSTBSB7106TBSB71062026-05-22
G149TBSB71070TBS BASICSTBSB7107TBSB71072026-05-22
G149TBSB71080TBS BASICSTBSB7108TBSB71082026-05-22
G149TBSB71090TBS BASICSTBSB7109TBSB71092026-05-22
G149TBSB71100TBS BASICSTBSB7110TBSB71102026-05-22
G149TBSB71110TBS BASICSTBSB7111TBSB71112026-05-22
G149TBSB71120TBS BASICSTBSB7112TBSB71122026-05-22
G149TBSB71130TBS BASICSTBSB7113TBSB71132026-05-22
G149TBSB71140TBS BASICSTBSB7114TBSB71142026-05-22
G149TBSB71150TBS BASICSTBSB7115TBSB71152026-05-22
G149TBSB71160TBS BASICSTBSB7116TBSB71162026-05-22
G149TBSB71170TBS BASICSTBSB7117TBSB71172026-05-22
G149TBSB71180TBS BASICSTBSB7118TBSB71182026-05-22
G149TBSB71190TBS BASICSTBSB7119TBSB71192026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
J003SVN620451Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003SVN650901Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003VXSV620451Vortex Size VerifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J0036692981Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693001Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693011Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693021Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693031Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693041Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693051Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693061Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693071Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693081Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF11Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF21Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF31Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF41Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF51Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVAST1Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX21Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX31Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX41Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX51Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVAST1Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVF11Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVF21Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26