FDA.reportPublic FDA data

TBS BASICS

Primary DI
G149TBSB1250
Brand
TBS BASICS
Company
ACME ENTERPRISE.
Model
TBSB125
Catalog number
TBSB125
Device description
TBS BASICS Orthodontic Direct Bond Bracket Holder, Curved
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
ECQAligner, Bracket, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECQAligner, Bracket, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G149TBSB1250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

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
G859PT20260010Clear Moves AlignerCLEAR MOVES ALIGNERSECQ2026-05-22
G149TBSB1240TBS BASICSACME ENTERPRISE.ECQ2026-05-20
D175H3DMTA91MemoryTech AlignersHype Align Clear Orthodontics LimitadaECQ2026-02-10
D90970000913ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097000111ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001011ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001021ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970010M1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001111ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011511ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011713ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D909700117L1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011814ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011915ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D909700119S1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970012310ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970013210ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
00371347018332Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
00371347018349Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
00723896026847SMILEGOODS ALIGNER CHEWIES MINT 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026854SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026878SMILEGOODS ALIGNER CHEWIES MINT PRACTICON, INC.ECQ2024-08-07
00723896026885SMILEGOODS ALIGNER CHEWIES UNSCENTED PRACTICON, INC.ECQ2024-08-07
00723896026892SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026908SMILEGOODS ALIGNER CHEWIES ASSORTED PRACTICON, INC.ECQ2024-08-07
D90946300111ECLIPSE PASSIVE Ortho Arch Company IncECQ2023-06-20
D90946161116ECLIPSE INTERACTIVEOrtho Arch Company IncECQ2023-06-14
D909270106103LINGUAL BUTTON Ortho Arch Company IncECQ2023-06-13
D90927010613WELDABLE LINGUAL BUTTONSOrtho Arch Company IncECQ2023-06-13
D90927020210DIRECT BOND BUTTONOrtho Arch Company IncECQ2023-06-13