FDA.reportPublic FDA data

NORDENT MANUFACTURING INC

Primary DI
00840018642157
Brand
NORDENT MANUFACTURING INC
Company
NORDENT MANUFACTURING INC
Model
ECSM11
Device description
BONE CURETTE M11 - DURALITE HA
Published
2020-06-18
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
EMKCurette, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018642157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018642157008400186421578400186421570840018642157

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00348783007831Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-03-17
B382SD9162110970Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD916211098Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD9162111000Surgical DirectSurgical Direct, Inc.EMK2026-03-02
G1493800400TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493800501TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493806204TBS DentalACME ENTERPRISE.EMK2026-03-02
G149TBSBP03TBS DentalACME ENTERPRISE.EMK2026-03-02
B382SD915585140Surgical DirectSurgical Direct, Inc.EMK2026-02-25
B382SD48713950600Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800240Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48810120Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000500Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570050Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915579000Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915580070Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155911020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
00841336106000Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106062Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106079Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106239Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106499Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106697Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106918Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336108639Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336108653Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336109421Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22