GC Reline™ II
GC Reline II is a resilient vinyl polysiloxane silicone for soft relining of dentures. Base and catalyst pastes dispense from a cartridge through an automixing tip and set through chemical…
GC Reline II is a resilient vinyl polysiloxane silicone for soft relining of dentures. Base and catalyst pastes dispense from a cartridge through an automixing tip and set through chemical polymerization.
The material comes in Soft, Extra Soft and Extra Extra Soft viscosities. A resin primer provides adhesion to the denture base, while the cartridge and mixing tip deliver the two components together.
Listed Item
GC RELINE II™ Intro Kit ExtraExtraSoft contains: 1 GC RELINE II cartridge ExtraExtraSoft 55g (48mL), 1 GC RELINE II Primer for Resin 8g (10mL), 1 GC RELINE II Point for Trimming, 1 GC Reline II Wheel for Finishing, 1 GC Reline II Remover for Resin 5g (5.5mL), 6 pieces Mixing Tip II L, 3 Disposable brushes, 1 Plastic spatula
Surface Modification
GC Reline Modifier uses equal amounts of liquids A and B mixed on a pad to activate an existing reline surface for additional Reline II material. The kit family includes the appropriate relining material and supporting application or finishing accessories.
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 | GC America Inc., United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K153253 |
| Record published | 2017-10-06 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 25 °C; Storage environment temperature 59 to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010272 | In distribution | |
| 010270 | In distribution | |
| 010274 | In distribution | |
| 010282 | In distribution | |
| 010258 | In distribution | |
| 010274 | In distribution | |
| 010267 | In distribution | |
| 010256 | In distribution | |
| 010279 | In distribution | |
| 010267 | In distribution | |
| 010257 | In distribution | |
| 010256 | In distribution | |
| 010282 | In distribution | |
| 010279 | In distribution | |
| 010258 | In distribution | |
| 010261 | In distribution | |
| 010270 | In distribution | |
| 010276 | In distribution | |
| 010261 | In distribution | |
| 010257 | In distribution | |
| 010264 | In distribution | |
| 010264 | In distribution | |
| 010276 | In distribution | |
| 010272 | In distribution |
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 |
|---|---|
| K153253 | 2016-03-03 |
| K070697 | 2007-03-29 |
| K070698 | 2007-03-29 |
| K051358 | 2005-07-07 |
| K991774 | 1999-07-09 |
| K990736 | 1999-05-28 |
| K984365 | 1999-02-25 |
| K982695 | 1998-10-19 |
| K963144 | 1996-10-29 |
| K940565 | 1994-05-04 |
| K935261 | 1994-01-26 |
| K930939 | 1994-01-21 |
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.