FDA.reportPublic FDA data

NORDENT MANUFACTURING INC

Primary DI
00840018623873
Brand
NORDENT MANUFACTURING INC
Company
NORDENT MANUFACTURING INC
Model
RENSN137
Device description
SCALETTE, DOUBLE END, ANTERIOR #N137, XDURA DURALITE ROUND HANDLE
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELAInstrument, Hand, Calculus Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELAInstrument, Hand, Calculus RemovalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018623873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018623873008400186238738400186238730840018623873

GMDN Terms#

Term, Definition table
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 table
Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

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
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
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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