Silverstein
Packing 1428005 6PK Long Strips Polyest
2manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Suzhou Laixin 3D Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 6 |
Record
| Listed by | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | NOK |
| Device type | Material, External Aesthetic Restoration, No Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-10-13 |
| Record revised | 2023-08-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 6.4 mm; width 31.2 to 50.8 mm |
| Distribution end date | 2023-12-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1425020 | 6 | Withdrawn | |
| 1428010 | Length 6.4 mm | 6 | Withdrawn |
| 1428005 | Length 6.4 mm | 6 | Withdrawn |
| 1425015 | Length 6.4 mm | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 1,166 |
| Gingivamoll | Preat Corporation | 12 |
| Material, External Aesthetic Restoration, No Adhesive | Southern Implants (PTY) Ltd | 2 |
| Material, External Aesthetic Restoration, No Adhesive | Medtronic Xomed, Inc. | 2 |
| freeprint gingiva 385 1000g | Detax Gmbh | 1 |
| Gingivamoll pink 5g | Detax Gmbh | 1 |
| Gingivamoll Starter-Kit | Detax Gmbh | 1 |
| freeprint gingiva 385 500g | Detax Gmbh | 1 |
| Gingivamoll opaque 20g | Detax Gmbh | 1 |
| Gingivamoll light pink 5g | Detax Gmbh | 1 |
| Ultraprint-Dental Gingiva UV 1000g | Detax Gmbh | 1 |
| Gingivamoll paint liquid 15 ml | Detax Gmbh | 1 |
Showing 12 of 14. All products under Material, External Aesthetic Restoration, No Adhesive
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.