FDA.reportPublic FDA data

Nordent Manufacturing, Inc.

Primary DI
00840018661882
Brand
Nordent Manufacturing, Inc.
Company
NORDENT MANUFACTURING INC
Model
RECS918
Catalog number
Nordent Catalog Hygiene section
Device description
Sinus Lift Curette, DE, Sinus Lift Curette #918, DuraLite Round Handle
Published
2026-01-14
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
EMSCurette, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018661882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018661882008400186618828400186618820840018661882

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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
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G879102209H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
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G879102214H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
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G879102216H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
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G879GC780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
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G879GCM120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14