FDA UDI
In Commercial Distribution
🇺🇸 United States
Temptation NOW® A3 8g
DI: 07540172002097
·
Model: 152503
·
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Temptation NOW® A3 8g
- Primary DI
- 07540172002097
- Version / Model
- 152503
- Catalog Number
- 152503
- Company Name
- CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Labeler DUNS
- 626406016
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 22487479-9c9b-4c1b-b15d-b14b75acdf90
Device Description
Crown and Bridge Temporary Resin
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Dental | 872.4565 | 1 |
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45236 | Temporary dental crown/bridge resin | A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540172002097 | GS1 |
Customer Contacts
- Phone
- +1(800)265-3444
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 8 | Gram | |
| Device Size Text, specify | cartridge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to direct sunlight or the chairlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 23 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 73 Degrees Fahrenheit