Device
Periodontal File, DE, Hirschfield #9-10, Medium Round Handle
Manufacturer
NORDENT MANUFACTURING INC
NORDENT MANUFACTURING INC
Model: RFPH9-10
Catalog: Nordent Surgical Catalog
DI: 00840018674639
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Periodontal File, DE, Hirschfield #9-10, Medium Round Handle
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a6431365-6d3c-450d-982a-45ad05310f29
Distribution Status:
In Commercial Distribution
DUNS Number:
053187985
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840018674639
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35013
Name: Periodontal file/rasp, manual
Definition:
A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable device.
FDA Product Codes
ECS
Pusher, Band, Orthodontic
Device Sizes
Device Size - Size - @attributes - Unit:
Inch
Device Size - Size - @attributes - Value:
7
Device Size - Size Type:
Length
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling Low - @attributes - Value:
40
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
60
Item #1 - Storage Handling Type:
Handling Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling Low - @attributes - Value:
0
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling High - @attributes - Value:
350
Item #2 - Storage Handling Type:
Handling Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #3 - Storage Handling Low - @attributes - Value:
65
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #3 - Storage Handling High - @attributes - Value:
75
Item #3 - Storage Handling Type:
Storage Environment Temperature