FDA.reportPublic FDA data

NORDENT MANUFACTURING INC

Primary DI
00840018645516
Brand
NORDENT MANUFACTURING INC
Company
NORDENT MANUFACTURING INC
Model
CEFPS9-10
Device description
FILE PERIOD.,DE,SCHLUGER 9-10,
Published
2020-07-08
Public version status
New
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
EMRFile, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMRFile, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018645516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018645516008400186455168400186455160840018645516

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal file/raspA hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument 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 made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. 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
00840018665767Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00840018665774Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00841336110854Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2024-12-11
00813677024756PDT, Inc.PDT, INC.EMR2024-05-22
00842517113688Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517118973Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119048Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119055Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517106093Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106130Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
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00841336102286Salvin Goldman-Fox Periosteal Elevator - 17cmSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102385Salvin Molt 9Salvin Dental Specialties, Inc.EMR2023-08-10
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00841336102859Salvin Woodson Elevator - 7" (18cm)Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102866Salvin Bone File #12Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102873Salvin Bone File #10Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102880Salvin Bone File # 12CA Cross CutSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102897Salvin Bone File # 10CA Cross CutSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104150Salvin Molt #2 Single End InstrumentSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104167Salvin Molt 4 Single End InstrumentSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104181Salvin Periosteal-Tome™ Combination Periosteal Elevator & PeriotomeSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104280Salvin Prichard ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104327PCHARLES Periosteal ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336105423Papilla Elevator BlackSalvin Dental Specialties, Inc.EMR2023-08-10
00841336105447Prichard BlackSalvin Dental Specialties, Inc.EMR2023-08-10
10889950012304Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMR2023-06-27