Advance Dental Products
Advance Mail In Biological Indicators
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | THE Atlanta Dental Supply Company, United States |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Repacker / relabeller |
| 510(k) | K023716 |
| Record published | 2023-02-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ADPVT-52 | 52 | In distribution | |
| ADPST-12 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bionova® | Terragene S.A. | 47 |
| Attest™ | 3M Company | 36 |
| Verify | Steris Corporation | 27 |
| 3M™ Attest™ | 3M Company | 16 |
| Celerity | Steris Corporation | 15 |
| Biotrace™ | Terragene S.A. | 11 |
| Single Species BI Strip | Crosstex International | 11 |
| Tuttnauer® | Terragene S.A. | 10 |
| Sterrad Velocity™ | Advanced Sterilization Products Services Inc. | 8 |
| GPS | Group Practice Solutions | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Propper Duo Spore Biological Indicators | Propper Manufacturing Co., Inc. | 7 |
Showing 12 of 173. All products under Indicator, Biological Sterilization Process
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| HF Acquisition Co. LLC | 510(k) number | 2024-12-11 | Class II | Error in labeling | Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer’s account. | 4,021 |
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.