FDA.report

NORDENT MANUFACTURING INC

Primary DI
00840018624764
Brand
NORDENT MANUFACTURING INC
Company
NORDENT MANUFACTURING INC
Model
TRNSNMJ
Device description
SCALER, DOUBLE END, OFFSET SICKLE MONTANA JACK UNIVERSAL R138, XDURA DURALITE ROUND HANDLE
Published
2020-08-25
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

Related Records

Product Codes

CodeName
ELAInstrument, Hand, Calculus Removal

Product Code Classifications

CodeDeviceSpecialtyClass
ELAInstrument, Hand, Calculus RemovalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840018624764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018624764008400186247648400186247640840018624764

GMDN Terms

TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
00840018674530Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-14
00840018674417Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674424Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674431Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674455Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674462Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674479Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674523Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674363Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-11
00840018674387Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-11
00840018674394Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-11
00840018674400Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-11
00840018674233Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-02
00840018674240Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-02
00840018672918Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673854Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673861Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673878Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673885Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673892Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673991Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674004Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674066Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674073Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674080Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674110Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674196Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674202Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
10810132809443House Brand DentistryFrontier Dental Supply IncELA2026-02-10
00840018667266Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-10