Hygenic
5 lb Lab Pack Hyg Repair Resin - Special Veined
14manufacturers in China registered for this device type
152catalogue numbers in this listing
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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K900301 |
| Record published | 2016-06-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H01038 | In distribution | |
| H00025 | In distribution | |
| H01020 | In distribution | |
| H00269 | In distribution | |
| H00337 | In distribution | |
| H00311 | In distribution | |
| H00020 | In distribution | |
| H00391 | In distribution | |
| H00383 | In distribution | |
| H03343 | In distribution | |
| H00367 | In distribution | |
| H02099 | In distribution | |
| H00411 | In distribution | |
| H00395 | In distribution | |
| H00273 | In distribution | |
| H00098 | In distribution | |
| H00340 | In distribution | |
| H00205 | In distribution | |
| H00390 | In distribution | |
| H00122 | In distribution | |
| H00174 | In distribution | |
| H00293 | In distribution | |
| H00280 | In distribution | |
| H00355 | In distribution | |
| H00243 | In distribution | |
| H00405 | In distribution | |
| H00272 | In distribution | |
| H00109 | In distribution | |
| H00406 | In distribution | |
| H00392 | In distribution | |
| H00060 | In distribution | |
| H00242 | In distribution | |
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| H00321 | In distribution | |
| H00370 | In distribution | |
| H00288 | In distribution | |
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| H00039 | In distribution | |
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| H00345 | In distribution | |
| H00369 | In distribution | |
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| H00304 | In distribution | |
| H03342 | In distribution | |
| H00179 | 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 |
| 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 |
| Karadent by TCS | Thermoplastic Comfort SYS | 91 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
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.