FDA UDI
In Commercial Distribution
🇺🇸 United States
Choice 2 Try-In Paste
DI: 00810111540698
·
Model: C-412B1
·
BISCO INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Choice 2 Try-In Paste
- Primary DI
- 00810111540698
- Version / Model
- C-412B1
- Catalog Number
- C-412B1
- Company Name
- BISCO INC.
- Labeler DUNS
- 053529939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-11
- Public Version
- 1
- Public Version Date
- 2022-10-19
- Public Version Status
- New
- Public Device Record Key
- 9f1ec29c-bd78-4c52-b01c-a8bf3d10e8ad
Device Description
Choice 2 Try-In Paste B1 2g Syringe
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 |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61482 | Dental cement trial | A non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. 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 | 00810111540698 | GS1 | ||||
| Previous | D757C412B10 | HIBCC |
Customer Contacts
- Phone
- +1(847)534-6000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993192 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius