Stradis
Custom Convenience KIT Surgical Pack
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
All of them in Hebei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | OFY |
| Device type | Dental Implant Surgical Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Premarket notification | Exempt |
| Record published | 2016-06-15 |
| Record revised | 2023-01-31 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2023-01-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40389WYI | Withdrawn | |
| 40797FIP | Withdrawn | |
| 40181TOI | Withdrawn | |
| 40199PLTD | Withdrawn | |
| 20273CDP | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Intra-Lock | Intra-Lock International | 31 |
| Ditron Dental | Ditron Dental Ltd | 10 |
| Restore | Keystone Dental Inc. | 9 |
| Prima | Keystone Dental Inc. | 9 |
| Stage-1 | Keystone Dental Inc. | 7 |
| DIO Master Kit | DIO Corporation | 6 |
| Genesis | Keystone Dental Inc. | 5 |
| TRI | TRI Dental Implants INT. AG | 5 |
| FTN Surgical Kit | DIO Corporation | 5 |
| UF(II) Starter Kit | DIO Corporation | 4 |
| RS-Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills | Adin Dental Implant Systems Ltd. | 3 |
| RS-Standard Internal Hex Plastic Surgical Kit-Starter | Adin Dental Implant Systems Ltd. | 3 |
Showing 12 of 110. All products under Dental Implant Surgical Tray
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.