FDA.reportPublic FDA data

Nordent Manufacturing, Inc.

Primary DI
00840018663367
Brand
Nordent Manufacturing, Inc.
Company
NORDENT MANUFACTURING INC
Model
CEKOR1-2
Catalog number
Nordent Instruments-Surgical
Device description
Periodontal Knife, DE, Orban #1-2, DuraLite ColorRings Handle
Published
2026-02-04
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
EMOKnife, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMOKnife, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018663367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018663367008400186633678400186633670840018663367

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting 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
00840018674011Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-11
00840018666009Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-09
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLEW.H. Holden, Inc.EMO2026-01-14
D9284001040D9284001040W.H. Holden, Inc.EMO2026-01-14
00841013121050Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121067Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121074Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121128Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121135Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121142Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121159Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
D9284005451HF0VESTIBULAR TUNNELING ELEVATOR #1 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005452HF0VESTIBULAR TUNNELING ELEVATOR #2 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005453HF0VESTIBULAR TUNNELING ELEVATOR #3 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005454HF0VESTIBULAR TUNNELING ELEVATOR #4 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005455HF0VESTIBULAR TUNNELING ELEVATOR #5 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005456HF0VESTIBULAR TUNNELING ELEVATOR #6 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
00840105223757ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223764ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223771ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223788ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223795ZOLL DENTALZoll-DentalEMO2025-08-06
D928400531HFDLC0PA TUNNELING INSTRUMENT #2 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400532HFDLC0PA TUNNELING INSTRUMENT #3 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400533HFDLC0PA TUNNELING INSTRUMENT #4 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400110HF0PERIO KNIFE, TOWNER 19/20, HFW.H. Holden, Inc.EMO2025-02-06
D928400530HFDLC0PA TUNNELING INSTRUMENT #1 D/E HF HANDLE DLCW.H. Holden, Inc.EMO2025-02-06