FDA UDI
In Commercial Distribution
🇺🇸 United States
DiaCemTempNE
DI: 08806383585873
·
Model: DiaCemTempNE 10g (A type)
·
DiaDent Group International
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DiaCemTempNE
- Primary DI
- 08806383585873
- Version / Model
- DiaCemTempNE 10g (A type)
- Catalog Number
- A2003-3101
- Company Name
- DiaDent Group International
- Labeler DUNS
- 687789453
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-16
- Public Version
- 1
- Public Version Date
- 2022-08-24
- Public Version Status
- New
- Public Device Record Key
- 18df1da2-083d-46d4-9734-84c47e19b415
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMB | Zinc Oxide Eugenol | Dental | 872.3275 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16703 | Ethoxy benzoic acid dental cement | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806383585873 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry and away from Sunlight