FDA.reportPublic FDA data

NORDENT MANUFACTURING INC

Primary DI
00840018629035
Brand
NORDENT MANUFACTURING INC
Company
NORDENT MANUFACTURING INC
Model
CAFR2-3
Device description
CARVER, FRAHM 2-3, STD HANDLE
Published
2020-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKHCarver, Dental Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018629035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018629035008400186290358400186290350840018629035

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840018674509Nordent Manufacturing, Inc. OPPLN3-4MMNordent Hygiene Catalogue2026-03-12
00840018674516Nordent Manufacturing, Inc. PC11Q/6Nordent Instruments-Diagnostic2026-03-12
00840018674523Nordent Manufacturing, Inc. CV110/BG6Nordent Hygiene Catalogue2026-03-12
00840018674295Nordent Manufacturing, Inc. OPGGR11-12LNordent Hygiene Catalogue2026-03-11
00840018674301Nordent Manufacturing, Inc. OPGGR1-2Nordent Hygiene Catalogue2026-03-11
00840018674318Nordent Manufacturing, Inc. OPGGR1-2LNordent Hygiene Catalogue2026-03-11
00840018674325Nordent Manufacturing, Inc. OPGGR13-14Nordent Hygiene Catalogue2026-03-11
00840018674332Nordent Manufacturing, Inc. OPGGR13-14LNordent Hygiene Catalogue2026-03-11
00840018674349Nordent Manufacturing, Inc. OPGGR15-16Nordent Hygiene Catalogue2026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783009156Premier CarversPREMIER DENTAL PRODUCTS COMPANYEKH2026-03-17
00348783009231Premier CarversPREMIER DENTAL PRODUCTS COMPANYEKH2026-03-17
00840018674035Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674134Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674141Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674158Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
05010058180185InstrapacROBINSON HEALTHCARE LIMITEDEKH2025-06-23
00889813066058Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066065Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066089Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066096Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066102Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066119Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066126Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066133Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066140Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00841013116803American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKH2024-11-06
00813677025111PDT, Inc.PDT, INC.EKH2024-07-05
00813677021465PDT, Inc.PDT, INC.EKH2024-06-27
00842517106970Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517106987Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517106994Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107007Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107014Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107021Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107038Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118225Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118683Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118690Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118706Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06