Reform Ti Modular
Modular Fenestrated Bone-Screw - 9.5 mm x 60 mm
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 | Precision Spine, 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 | Manufacturer |
| 510(k) | K242297 |
| Record published | 2026-01-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 39-SF-9560 | 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 |
| 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 |
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.