JET Denture Repair
Fast Curing Denture Repair Acrylic Resin Powder AND Liquid
14manufacturers in China registered for this device type
59catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Lang Dental Manufacturing Co., Inc., United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| 510(k) | K072580 |
| Record published | 2022-04-15 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.3 KG F1 | In distribution | |
| POUND PACKAGE LIGHT FIBRED PINK | In distribution | |
| POUND PACKAGE FIBRED PINK #76 | In distribution | |
| POUND PACKAGE F2 | In distribution | |
| FIVE POUND PACKAGE CLEAR | In distribution | |
| POUND PACKAGE CP21 | In distribution | |
| FIVE POUND PACAKGE CP21 | In distribution | |
| PROFESSIONAL PACKAGE F1 | In distribution | |
| FIVE POUND PACKAGE FIBRED PINK | In distribution | |
| POUND PACKAGE F1 | In distribution | |
| PROFESSIONAL PACKAGE F2 | In distribution | |
| 11.3 KG P1 | In distribution | |
| 11.3 KG F2 | In distribution | |
| SAMPLE KIT PINK | In distribution | |
| POUND PACKAGE MEHARR | In distribution | |
| 45.4 KG F1 | In distribution | |
| 454 GRAMS F1 | In distribution | |
| 454 GRAMS F3 | In distribution | |
| 2.3 KG F3 | In distribution | |
| 100 GRAM PINK | In distribution | |
| PROFESSIONAL PACKAGE MEHARRY | In distribution | |
| PROFESSIONAL PACKAGE F3 | In distribution | |
| POUND PACKAGE P1 | In distribution | |
| FIVE POUND PACKAGE MEHARRY | In distribution | |
| PROFESSIONAL PACAKGE FIBRED PINK #76 | In distribution | |
| PROFESSIONAL PACKAGE FIBRED PINK | In distribution | |
| PROFESSIONAL PACKAGE FIBRED PINK #75 | In distribution | |
| POUND PACKAGE PINK | In distribution | |
| 100 GRAMS F2 | In distribution | |
| 100 GRAMS B1 | In distribution | |
| 45.4 KG B1 | In distribution | |
| PROFESSIONAL PACKAGE P1 | In distribution | |
| POUND PACKAGE B1 | In distribution | |
| POUND PACKAGE CLEAR | In distribution | |
| 11.3 KG F3 | In distribution | |
| FIVE POUND PACKAGE LIGHT FIBRED PINK | In distribution | |
| PROFESSIONAL PACKAGE CP21 | In distribution | |
| PROFESSIONAL PACKAGE CLEAR | In distribution | |
| 45.4 KG P1 | In distribution | |
| 454 GRAMS F2 | In distribution | |
| POUND PACKAGE FIBRED PINK #75 | In distribution | |
| 11.3 KG B1 | In distribution | |
| 454 GRAMS P1 | In distribution | |
| 45.4 KG F3 | In distribution | |
| FIVE POUND PACKAGE PINK | In distribution | |
| 2.3 KG B1 | In distribution | |
| 454 GRAMS CP21 | In distribution | |
| 454 GRAMS B1 | In distribution | |
| 100 GRAMS F1 | In distribution | |
| PROFESSIONAL PACKAGE LIGHT FIBRED PINK | In distribution | |
| 2.3 KG F2 | In distribution | |
| 45.4 KG F2 | In distribution | |
| POUND PACKAGE F3 | In distribution | |
| 100 GRAMS P1 | In distribution | |
| 2.3 KG P1 | In distribution | |
| 11.3 KG F1 | In distribution | |
| POUND PACKAGE FIBRED PINK | In distribution | |
| 100 GRAMS F3 | In distribution | |
| PROFESSIONAL PACKAGE B1 | 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 |
|---|---|
| K163482 | 2017-05-31 |
| K152981 | 2016-09-02 |
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.