Material, External Aesthetic Restoration, No Adhesive
Packing 1428005 6PK Long Strips Polyest
2manufacturers in China registered for this device type
2catalogue 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 | 2021-02-21 |
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 | Width 31.2 to 50.8 mm; length 6.4 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1428005 | Width 50.8 mm | 6 | In distribution |
| 1428010 | Length 6.4 mm | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 1,166 |
| Gingivamoll | Preat Corporation | 12 |
| Silverstein | Medtronic Xomed, Inc. | 4 |
| Material, External Aesthetic Restoration, No Adhesive | Southern Implants (PTY) Ltd | 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.