Gingivamoll Opaque 20g
Catalogue number 030241, listed by Detax Gmbh, Germany, under Material, External Aesthetic Restoration, No Adhesive. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Detax Gmbh, Germany |
|---|---|
| FDA product code | NOK |
| Device type | Material, External Aesthetic Restoration, No Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3800 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-14 |
| Record revised | 2025-04-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-05-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 030241 | Withdrawn |
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 |
| 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 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.