FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bulk Fill Composite Unit Dose Kit
DI: D757H93030K1
·
Model: H-93030K
·
BISCO INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bulk Fill Composite Unit Dose Kit
- Primary DI
- D757H93030K1
- Version / Model
- H-93030K
- Catalog Number
- H-93030K
- Company Name
- BISCO INC.
- Labeler DUNS
- 053529939
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-05
- Public Version
- 5
- Public Version Date
- 2022-01-31
- Public Version Status
- Update
- Public Device Record Key
- aec4ee27-2cdb-4f5e-b671-1a11dba6b94e
- Distribution End Date
- 2022-01-17
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
- Yes
- 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 |
| KXR | Applicator, Resin | Dental | 872.3140 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | 872.3250 | 2 |
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62477 | Dental composite resin kit | A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. 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 | D757H93030K1 | HIBCC |
Customer Contacts
- Phone
- +1(847)534-6000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | sixe text |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius