FDA.reportPublic FDA data

Nordent Manufacturing, Inc.

Primary DI
00840018666511
Brand
Nordent Manufacturing, Inc.
Company
NORDENT MANUFACTURING INC
Model
EEC31LR
Catalog number
Nordent Instruments-Surgical
Device description
Endo Excavator, DE, #31LR, Hex Handle
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKCExcavator, Dental, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018666511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018666511008400186665118400186665110840018666511

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Fahrenheit350 Degrees Fahrenheit
Storage Environment Temperature65 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8474374780ashah@nordent.com

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898506841585QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843282QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843299QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843305QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843763QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843770QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843787QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506851799QuinelatoSchobell Industrial LtdaEKC2022-12-08
10889950010065HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010072HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010089HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010096HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010102HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010119HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010126HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010133HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010140HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010157HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010164HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010171HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010188HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010195HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010201HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010218HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010225HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010232HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010249HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010256HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010263HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010270HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12