FDA.reportPublic FDA data

NORDENT MANUFACTURING INC

Primary DI
00840018638914
Brand
NORDENT MANUFACTURING INC
Company
NORDENT MANUFACTURING INC
Model
EOTN119
Device description
ORTHO SCLR-BD STR DE #119 DL-H
Published
2020-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ECRSetter, Band, Orthodontic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018638914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018638914008400186389148400186389140840018638914

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal band pusherA hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
053187985
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840018674646SabraNAB2/6Nordent Diagnostic Cataloge2026-05-12
00840018674653Nordent Manufacturing, Inc. TCNSGRA13-14Nordent Hygiene Catalogue2026-05-12
00840018674622Nordent Manufacturing, Inc. BUR2892Nordent Restorative Catalouge2026-05-05
00840018674639Nordent Manufacturing, Inc. RFPH9-10Nordent Surgical Catalog2026-05-05
00008418674554Nordent Manufacturing, Inc. OPPLN3-4Nordent Hygiene Catalogue2026-04-10
00840018674578Nordent Manufacturing, Inc. CENSN128Nordent Hygiene Catalogue2026-04-10
00840018674585Nordent Manufacturing, Inc. SGR17-18/BG6Nordent Hygiene Catalogue2026-04-10
00840018674592Nordent Manufacturing, Inc. N113/BG6Nordent Restorative Catalouge2026-04-10
00840018674608Nordent Manufacturing, Inc. SCA204-4Nordent Hygiene Catalogue2026-04-10
00840018674530Nordent Manufacturing, Inc. TCNSN137Nordent Hygiene Catalogue2026-03-14
00840018674547Nordent Manufacturing, Inc. OPPLN1-2Nordent Hygiene Catalogue2026-03-14
00840018674554Nordent Manufacturing, Inc. oppln3-4Nordent Hygiene Catalogue2026-03-14
00840018674561Nordent Manufacturing, Inc. OPPLN5-6Nordent Hygiene Catalogue2026-03-14
00840018674417Nordent Manufacturing, Inc. OPGN2Nordent Hygiene Catalogue2026-03-12
00840018674424Nordent Manufacturing, Inc. OPGN4Nordent Hygiene Catalogue2026-03-12
00840018674431Nordent Manufacturing, Inc. OPGN5-48Nordent Hygiene Catalogue2026-03-12
00840018674455Nordent Manufacturing, Inc. OPGNE128-128Nordent Hygiene Catalogue2026-03-12
00840018674462Nordent Manufacturing, Inc. OPGNMJNordent Hygiene Catalogue2026-03-12
00840018674479Nordent Manufacturing, Inc. OPGNMJTNordent Hygiene Catalogue2026-03-12
00840018674493Nordent Manufacturing, Inc. OPPM17S-18SNordent Hygiene Catalogue2026-03-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00889813063699Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECR2024-11-30
00813677022967PDT, Inc.PDT, INC.ECR2024-07-05
00813677022974PDT, Inc.PDT, INC.ECR2024-07-05
00840326420836Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
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00840326420928Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
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10840326420956Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
D1272421031Artman Instruments Wise Linkers, LLCECR2023-03-28
E89656540SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E8965654500SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E896495010SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-06
00817524028805J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00817524028812J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00850007728410ALIGNER SEATER PURPLEAccess Dental Lab, LLCECR2023-02-17
EZPF19080120HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-29
EZPF1926200WL0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-25
00840326408773OrthoquestYoung Innovations, Inc.ECR2022-11-03
00840326408803OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408770OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408800OrthoquestYoung Innovations, Inc.ECR2022-11-03