ZirClean
ZIRCLEAN - 5 gram SYRINGE
3manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Liaoning (1), Guangdong (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
Record
| Listed by | Bisco, Inc., United States |
|---|---|
| FDA product code | PME |
| Device type | External Cleaning Solution |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K163171 |
| Record published | 2022-07-29 |
| Record revised | 2022-10-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Distribution end date | 2022-10-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B-7351 | In distribution | |
| B-7351 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Go-CHx Gel – 0.8% Chlorhexidine | Taub Products | 3 |
| UniClean | Vista Dental | 1 |
| Detail™ Pre-Impression Cleansing Gel | Clinician’S Choice Dental Products, Inc. | 1 |
| Resolve Cleansing Gel | Denali Corporation | 1 |
| ZrC Syringe Kit | Vista Dental | 1 |
| ZrC Bottle | Vista Dental | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163171 | 2017-04-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.