FDA UDI
In Commercial Distribution
🇺🇸 United States
ZirClean
DI: 00810111542470
·
Model: B-7351
·
BISCO INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ZirClean
- Primary DI
- 00810111542470
- Version / Model
- B-7351
- Catalog Number
- B-7351
- Company Name
- BISCO INC.
- Labeler DUNS
- 053529939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-29
- Public Version
- 1
- Public Version Date
- 2022-08-08
- Public Version Status
- New
- Public Device Record Key
- dcd7c7ec-f54b-4691-818e-924be6106a3b
Device Description
ZIRCLEAN - 5 gram 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 |
|---|---|---|---|---|
| PME | External Cleaning Solution | Dental | 872.3260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62929 | Dental restoration fixation cleaning solution | A non-sterile liquid substance intended to be used to extra-orally clean the adherent surface of a dental restorative/prosthetic device (e.g., veneer, crown, inlay, onlay), after it has been assessed in situ as a trial, to improve adhesion when it is permanently fixed in place. The solution is typically a water-based gel containing potassium hydroxide supplied in a syringe with a number of applicator tips. It is not intended to be used as a tooth etching solution. 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 | 00810111542470 | GS1 | ||||
| Previous | D757B73510 | HIBCC |
Customer Contacts
- Phone
- +1(847)534-6000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163171 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius