FDA UDI
In Commercial Distribution
🇺🇸 United States
Quantium
DI: 00810111543170
·
Model: H-101B1
·
BISCO INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Quantium
- Primary DI
- 00810111543170
- Version / Model
- H-101B1
- Catalog Number
- H-101B1
- Company Name
- BISCO INC.
- Labeler DUNS
- 053529939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-14
- Public Version
- 1
- Public Version Date
- 2025-07-22
- Public Version Status
- New
- Public Device Record Key
- dd847bfb-9fc1-47a3-9fbd-5840750b9118
Device Description
Quantium B1 Body Unit Dose (0.25g)
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810111543177 | GS1 | Item No: H-1011B1 | 20 | In Commercial Distribution | |
| Primary | 00810111543170 | GS1 | ||||
| Package | 20810111543174 | GS1 | Item No: H-1011B1P | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(847)534-6000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242816 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius