Device
This product is a non-eugenol type dental adhesive cement that corresponds to type 1 (for temporary cementation) according to the classification of ISO3107. Zinc oxide reacts with...
Manufacturer
DiaDent Group International
DiaDent Group International
Model: DIACEM TEMPNE 3g(Type S)
Catalog: A2004-6912
DI: 08806383591690
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
This product is a non-eugenol type dental adhesive cement that corresponds to type 1 (for temporary cementation) according to the classification of ISO3107. Zinc oxide reacts with 2-ethoxybenzoic acid to have relatively low adhesion and strength and is used for temporary bonding.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
54e87960-3064-40f4-8ae1-95e27821f867
Distribution Status:
In Commercial Distribution
DUNS Number:
687789453
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08806383591690
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16703
Name: Ethoxy benzoic acid dental cement
Definition:
A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between ethoxy benzoic acid (EBA) and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.
FDA Product Codes
EMB
Zinc Oxide Eugenol
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
2
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
27
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep Dry and away from Sunlight