FDA.reportPublic FDA data

J&J Instruments

Primary DI
00817524028812
Brand
J&J Instruments
Company
J & J INSTRUMENTS INC
Model
55-0009
Catalog number
55-0009
Device description
"BRACKET PLACER 4.25"" POSTERIOR"
Published
2023-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ECQAligner, Bracket, Orthodontic
ECRSetter, Band, Orthodontic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817524028812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524028812008175240288128175240288120817524028812

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracket open/close toolA hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
783328149
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817524029963J&J Instruments03-50003-5002023-10-10
00817524029970J&J Instruments09-50009-5002023-10-10
00817524027846J&J Instruments42-123042-12302023-03-01
00817524027853J&J Instruments42-127042-12702023-03-01
00817524022865J&J Instruments07-2002019-10-07
00817524020328J & J INSTRUMENTS02-010 02-010 2018-05-31
00817524020335J & J INSTRUMENTS02-02002-0202018-05-31
00817524020359J & J INSTRUMENTS02-10102-1012018-05-31
00817524020397J & J INSTRUMENTS02-275 02-275 2018-05-31
00817524020403J & J INSTRUMENTS02-28502-2852018-05-31
00817524020410J & J INSTRUMENTS02-28602-2862018-05-31
00817524020427J & J INSTRUMENTS02-28702-2872018-05-31
00817524020434J & J INSTRUMENTS02-28802-2882018-05-31
00817524020441J & J INSTRUMENTS02-29102-2912018-05-31
00817524020458J&J Instruments02-292 02-292 2018-10-16
00817524020465J&J Instruments02-293 02-293 2018-10-16
00817524020472J&J Instruments02-294 02-294 2018-10-16
00817524020489J&J Instruments02-295 02-295 2018-10-16
00817524020496J&J Instruments02-296 02-296 2018-10-16
00817524020618J & J INSTRUMENTS INC02-50002-5002018-10-17

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Primary DI, Brand, Company table
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00371347018332Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
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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
00813677022967PDT, Inc.PDT, INC.ECR2024-07-05