FDA UDI
In Commercial Distribution
🇺🇸 United States
Estemp NE Temporary Cement
DI: 08809262954227
·
Model: 101-1012
·
Spident Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Estemp NE Temporary Cement
- Primary DI
- 08809262954227
- Version / Model
- 101-1012
- Catalog Number
- 101-1012
- Company Name
- Spident Co., Ltd.
- Labeler DUNS
- 689370711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-23
- Public Version
- 4
- Public Version Date
- 2022-08-11
- Public Version Status
- Update
- Public Device Record Key
- 61d36bb5-3124-4971-8c43-40db5ef2bcb7
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| EMA | Cement, Dental | Dental | 872.3275 | 2 |
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 | 08809262954227 | GS1 | ||||
| Package | 00202102110667 | GS1 | 54 | Not in Commercial Distribution | 2021-01-25 | |
| Package | 00202102110650 | GS1 | 96 | Not in Commercial Distribution | 2021-01-25 | |
| Package | 00000202208198 | GS1 | 120 | Not in Commercial Distribution | 2022-08-11 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100290 | 000 |