FDA.reportPublic FDA data

NATIONAL DISTRIBUTION & CONTRACTING INC.

Primary DI
00840018601024
Brand
NATIONAL DISTRIBUTION & CONTRACTING INC.
Company
NORDENT MANUFACTURING INC
Model
BB27-29Q
Device description
BURNISHER DE #27/29 QUALA
Published
2020-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKJBurnisher, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018601024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018601024008400186010248400186010240840018601024

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
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
Contains natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783009361Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-03-17
00840018667389Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018671508Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018672314Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018665729Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018666139Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018662247Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
00840018662896Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
05010058178090InstrapacROBINSON HEALTHCARE LIMITEDEKJ2025-06-23
00889813065884Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065891Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065907Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065914Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065921Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065945Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813066157Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065938Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-10-01
00813677025159PDT, Inc.PDT, INC.EKJ2024-09-11
00813677025166PDT, Inc.PDT, INC.EKJ2024-09-11
00842517118652Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118669Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118676Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
08800075604774OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-03-04
08800075604750OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08800075604767OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08800075624000OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08964003163297NivoB. Ali ImpexEKJ2024-01-27
08964003163303NivoB. Ali ImpexEKJ2024-01-27
10889950112929Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKJ2023-07-19
10889950114046Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKJ2023-06-27