FDA.reportPublic FDA data

Buccal Tube Bonder Tweezer

Primary DI
00190707102845
Brand
Buccal Tube Bonder Tweezer
Company
Ortho Organizers, Inc.
Model
200-324
Device description
Buccal Tube Bonder Tweezer
Published
2022-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00190707102845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707102845001907071028451907071028450190707102845

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707089078Endura Plus Instruments201-1212020-07-13
00190707000738Envision701-005-52016-09-24
00190707000745Envision701-006-52016-09-24
00190707000752Envision701-021-52016-09-24
00190707000769Envision701-022-52016-09-24
00190707000776Envision701-033-52016-09-24
00190707000783Envision701-034-52016-09-24
00190707000790Envision701-035-52016-09-24
00190707000806Envision701-036-52016-09-24
00190707000813Envision701-037-52016-09-24
00190707000820Envision701-038-52016-09-24
00190707000837Envision701-057-52016-09-24
00190707000844Envision701-058-52016-09-24
00190707000851Envision701-059-52016-09-24
00190707000868Envision701-060-52016-09-24
00190707000875Envision701-067-52016-09-24
00190707000882Envision701-068-52016-09-24
00190707000899Envision701-069-52016-09-24
00190707000905Envision701-070-52016-09-24
00190707000912Envision701-087-52016-09-24

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Primary DI, Brand, Company table
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G149TBSB1240TBS BASICSACME ENTERPRISE.ECQ2026-05-20
G149TBSB1250TBS 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
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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