Model: BUR2892
Catalog: Nordent Restorative Catalouge
DI: 00840018674622
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
BANDITT 28-29 BURNISHER, DE, EGG, #4 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:
03a28a77-5abc-4c90-92c6-4354d81db449
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:
00840018674622
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64078
Name: Manual dental burnisher, reusable
Definition:
A hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.
FDA Product Codes
EKJ
Burnisher, Operative
Device Sizes
Device Size - Size - @attributes - Unit:
Inch
Device Size - Size - @attributes - Value:
7.0
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