Fiber Force
Fiber Force reinforces dental restorations using E-glass fibers preimpregnated with light-curing resin. The fibers integrate with acrylic or composite resin to provide structural…
Fiber Force reinforces dental restorations using E-glass fibers preimpregnated with light-curing resin. The fibers integrate with acrylic or composite resin to provide structural reinforcement in selected prosthetic and splinting applications.
The treated glass fibers are impregnated through a manufacturing process intended to distribute resin uniformly. The listed braided rope is one format within the reinforcing material system.
Listed Item
White Braided Rope 2MM ( 2-150MM)
Dental Applications
Indications include fabricating or repairing removable dentures and implant-supported dentures, reinforcing plastic or composite crowns and bridges, and making customized splints to immobilize natural teeth. It supports the restorative material rather than replacing the complete prosthesis.
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Synca Marketing, Canada |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Repacker / relabeller, Exporter |
| 510(k) | K102207 |
| Record published | 2016-10-04 |
| Record revised | 2021-07-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 12 to 30 °C |
| Sizes | Length 150 mm |
| Distribution end date | 2021-07-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FF08001 | Length 150 mm | 2 | In distribution |
| FF08002 | Length 150 mm | 2 | In distribution |
| FF08011 | Length 150 mm | 2 | In distribution |
| FF08004 | 53MMX80MM | 2 | In distribution |
| FF08014 | Length 150 mm | 2 | In distribution |
| FF08002 | Length 150 mm | 2 | Withdrawn |
| FF08011 | Length 150 mm | 2 | Withdrawn |
| FF08014 | Length 150 mm | 2 | Withdrawn |
| FF08004 | 53mmX80mm | 2 | Withdrawn |
| FF08001 | Length 150 mm | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Nobilium | Cmp Industries, LLC | 167 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Unbreakable by TCS | Thermoplastic Comfort SYS | 96 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102207 | 2010-11-23 |
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.