Gingivamoll
Gingivamoll Starter Kit. Kit contains . 1 Gingivamoll Opaque 4g (00842092155752). 1 Gingivamoll Pink 2.5g (00842092155769). 1 Gingivamoll Light Pink 2.5g (00842092155776). 1 Gingivamoll…
Gingivamoll Starter Kit. Kit contains. 1 Gingivamoll Opaque 4g (00842092155752). 1 Gingivamoll Pink 2.5g (00842092155769). 1 Gingivamoll Light Pink 2.5g (00842092155776). 1 Gingivamoll Stain Liquid 5mL (00842092155783). 1 Gingivamoll Protective Lacquer 5mL (00842092155790). 1 Gingivamoll Red Stain 2g (00842092155806). 1 Gingivamoll Blue Stain 2g (00842092155813)
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 | Preat Corporation, 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 |
| Premarket notification | Exempt |
| Record published | 2022-10-25 |
| Record revised | 2024-01-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2022-10-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0906411 | Withdrawn | |
| 0906406 | Withdrawn | |
| 0906403 | Withdrawn | |
| 0900003 | Withdrawn | |
| 0906407 | Withdrawn | |
| 0900001 | Withdrawn | |
| 0900004 | Withdrawn | |
| 0906410 | Withdrawn | |
| 0906409 | Withdrawn | |
| 0906405 | Withdrawn | |
| 0906402 | Withdrawn | |
| 0906412 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 1,166 |
| 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 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.