FDA.reportPublic FDA data

Precision Dental Instruments

Primary DI
00850000052109
Brand
Precision Dental Instruments
Company
Precision Dental Instruments
Model
PI-9-6
Published
2019-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JEXPlier, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000052109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000052109008500000521098500000521090850000052109

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081290121
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000052567Precision Dental Instruments PI-9-1222019-01-27
00850000052901Precision Dental Instruments PI-9-1522019-01-27
00850000052925Precision Dental Instruments PI-9-1562019-01-27
00850000052949Precision Dental Instruments PI-9-1582019-01-27
00850000052017Precision Dental Instruments PDIPI-9-3PI-9-32019-01-27
00850000052024Precision Dental Instruments - PDIPI-9-52019-01-27
00850000052031Precision Dental Instruments PI-9-102019-01-27
00850000052048Precision Dental Instruments PI-9-11PI-9-112019-01-27
00850000052055Precision Dental Instruments PI-9-12PI-9-122019-01-27
00850000052062Precision Dental Instruments PI-9-132019-01-27
00850000052079Precision Dental Instruments PI-9-152019-01-27
00850000052086Precision Dental Instruments PI-9-19PI-9-192019-01-27
00850000052093Precision Dental Instruments PI-9-202019-01-27
00850000052123Precision Dental Instruments PI-9-222019-01-27
00850000052130Precision Dental Instruments PI-9-23PI-9-232019-01-27
00850000052161Precision Dental Instruments PI-9-27PI-9-272019-01-27
00850000052178Precision Dental Instruments PI-9-292019-01-27
00850000052185Precision Dental Instruments PI-9-30PI-9-302019-01-27
00850000052208Precision Dental Instruments PI-9-342019-01-27
00850000052215Precision Dental Instruments PI-9-352019-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840539702450ExperienceGc Orthodontics America Inc.JEX2026-05-28
07898488905107WEINGART PLIER W/OUT WIDIAORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07898488907217TUBE CONVERSION PLIER – 4003ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07898488909945ELASTIC LIGATURE APPLICATOR/REMOVERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908470705735PLIER ANGLE W/ WIDIA AND CUTTING (139)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908470705803TORQUE PLIER SHORT (442)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611200129PLIER FOR LONG TORQUE (442)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611204325ANGULAR BRACKET REMOVAL PLIERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611210074"PROMO KIT ICERAM-P MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2024-04-16
07898506853069QuinelatoSchobell Industrial LtdaJEX2023-01-10
07898506814039QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506814244QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506841318QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506848669QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506850228QuinelatoSchobell Industrial LtdaJEX2022-12-16
07895742204273MorelliDental Morelli LtdaJEX2021-04-30
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ESAM6073131STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6075001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6078001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6080001STOMA®Storz am Mark GmbHJEX2020-08-27