Nordent Manufacturing, Inc. Nordent Catalog Hygiene section

GUDID 00840018667730

XDURA, Curette, DE, Gracey # 1-2, O Style, DuraliteRound Handle

NORDENT MANUFACTURING INC

Periodontal curette
Primary Device ID00840018667730
NIH Device Record Key2c856eae-dc2a-462b-b957-337ecbf2ec9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNordent Manufacturing, Inc.
Version Model NumberRENSGR1-2O
Catalog NumberNordent Catalog Hygiene section
Company DUNS053187985
Company NameNORDENT MANUFACTURING INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com
Phone8474374780
Emailashah@nordent.com

Device Dimensions

Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch

Operating and Storage Conditions

Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 350 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100840018667730 [Primary]

FDA Product Code

EMSCurette, Periodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00840018667730]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-05
Device Publish Date2025-11-06

On-Brand Devices [Nordent Manufacturing, Inc. ]

00840018667983RESCGRA11-12
00840018667976Xdura, Curette, DE, Gracey #9-10, DuraLite® Round Handle
00840018667969Xdura, Curette, DE, Gracey #7-8, DuraLite® Round Handle
00840018667952Xdura, Curette, DE, Gracey #7-8 Long Reach, DuraLite® Round Handle
00840018667945Xdura, Curette, DE, Gracey #5-6, DuraLite® Round Handle
00840018667938Xdura, Curette, DE, Gracey #3-4, DuraLite® Round Handle
00840018667921Xdura, Curette, DE, Gracey #15-16, DuraLite® Round Handle
00840018667914Xdura, Curette, DE, Gracey #13-14, DuraLite® Round Handle
00840018667907Xdura, Curette, DE, Gracey #13-14 Long Reach, DuraLite® Round Handle
00840018667891Xdura, Curette, DE, Gracey #1-2, DuraLite® Round Handle
00840018667884Xdura, Curette, DE, Gracey #12-13, DuraLite® Round Handle
00840018667877Xdura, Curette, DE, Gracey #11-14, DuraLite® Round Handle
00840018667860RENSGRA11-12
00840018667853Xdura, Curette, DE, Gracey #11-12 Long Reach, DuraLite® Round Handle
00840018667839Classic, Curette, DE, Gracey #9-10, O Style, Medium Round Handle
00840018667822Classic, Curette, DE, Gracey #15-16, O Style, Medium Round Handle
00840018667815Classic, Curette, DE, Gracey #13-14 Long Reach, O Style, Medium Round Handle
00840018667808Classic, Curette, DE, Gracey #1-2, O Style, Medium Round Handle
00840018667785Classic, Curette, DE, Gracey #12-13, O Style, DuraLite® Round Handle
00840018667778Classic, Curette, DE, Gracey #11-14, O Style, DuraLite® Round Handle
00840018667754Xdura, Curetter, DE, Gracey #9-10, O Style, Durite Round Handle
00840018667730XDURA, Curette, DE, Gracey # 1-2, O Style, DuraliteRound Handle
00840018667723Xdura, Curette, DE, Gracey #12-13, O Style, DuraLite® Round Handle
00840018667716Curette, DE, Gracey #11-14, O Style, DuraLite® Round Handle
00840018667686CURETTE, DE, GRACEY #9-10 O STYLE, DURALITE ROUND HANDLE
00840018667563Curette, DE,Xdura,Trade, Univ of CA 3-4, Duralite ColorRings Handle
00840018667532Curette, DE,Gracey #15-16, Old Style, DXDURA Round Handle
00840018667471Curette, DE, Gracey #11-12, Long OLD STYLE, XDURA ROUND Handle
00840018667433Curette, DE, Gracey #11-12, Long OLD STYLE, XDURA ROUND Handle
00840018667426Curette, DE, Gracey #13-14, Long Old Style, XDURA RUND Handle
00840018667419Curette, DE, Gracey #17-18,Old Style, XDURA Round Handle
00840018667402Curette, DE, Gracey #5-6, Old Style, XDURA Round Handle
00840018667136Curette, DE, University of California Ratcliff #3-4
00840018667112" XDURA CURETTE DE GRACEY #5-6 DL CC, OLD STYLE"
00840018667105CURETTE, DE, GRACEY #7-8, OLD STYLE, XDURA ROUND HANDLE
00840018667099CURETTE, DE, GRACEY #3-4, OLD STYLE, XDURA ROUND HANDLE
00840018666863XDURA CURETTE DE GRACEY #1-2 DL CC, OLD STYLE
00840018666856XDURA CURETTE DE GRACEY #13-14 LONG SHANK DL CC, OLD STYLE
00840018666849XDURA CURETTE DE GRACEY #11-12 LONG SHANK DL CC, OLD STYLE
00840018666832XDURA CURETTE DE GRACEY #1-2 LONG SHANK DL CC, OLD STYLE
00840018666504RENSGR3-4L
00840018666467CURETTE, DE, GRACEY #13-14, OLD STYLE, XDURA ROUND HANDLE
00840018665743XDURA CURETTE DE GRACEY #5-6 LONG
00840018663664Curette, DE, Xdura, Trade, Gracey #15-16 Mini Blade / Long Reach
00840018663619Curette, DE, Xdura, Gracey #15-16 Mini Blade, DuraLite Round Handle
00840018663602Curette, DE, Xdura, Gracey #17-18 Mini Blade, DuraLite Round Handle
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