HI-I®
Special Grain #2 Short Fibered HI-I® Self Curing
14manufacturers in China registered for this device type
490catalogue 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 | Fricke International, Inc. |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Premarket notification | Exempt |
| Record published | 2020-07-27 |
| Record revised | 2021-11-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Weight 1 to 48 lb; weight 48 to 145 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13046-006P | Weight 6 lb | In distribution |
| 20007-002 | Weight 48 g | In distribution |
| 11009-600P | Weight 145 g | In distribution |
| 20047-016 | Weight 1 lb | In distribution |
| 19013-002 | Weight 48 g | In distribution |
| 07008-006P | Weight 6 lb | In distribution |
| 13038-006 | Weight 145 g | In distribution |
| 13009-006P | Weight 6 lb | In distribution |
| 13029-025P | Weight 25 lb | In distribution |
| 13064-006P | Weight 6 lb | In distribution |
| 07027-048 | Weight 48 g | In distribution |
| 20053-002 | Weight 48 g | In distribution |
| 11005-006P | Weight 6 lb | In distribution |
| 11008-001P | Weight 1 lb | In distribution |
| 08001-048 | Weight 48 g | In distribution |
| 20041-006 | Weight 145 g | In distribution |
| 07008-048 | Weight 48 g | In distribution |
| 25120-001P | Weight 1 lb | In distribution |
| 05048-006P | Weight 6 lb | In distribution |
| 11032-025P | Weight 25 lb | In distribution |
| 20013-006 | Weight 145 g | In distribution |
| 20030-016 | Weight 1 lb | In distribution |
| 20025-016 | Weight 1 lb | In distribution |
| 13060-006P | Weight 6 lb | In distribution |
| 20052-016 | Weight 1 lb | In distribution |
| 11061-006P | Weight 6 lb | In distribution |
| 19071-006 | Weight 145 g | In distribution |
| A122-1P | Weight 1 lb | In distribution |
| 09015-006P | Weight 6 lb | In distribution |
| 11043-001P | Weight 1 lb | In distribution |
| 11023-006P | Weight 6 lb | In distribution |
| 25110-006 | Weight 145 g | In distribution |
| 13046-001P | Weight 1 lb | In distribution |
| 07017-006P | Weight 6 lb | In distribution |
| 11003-001P | Weight 1 lb | In distribution |
| 19040-002 | Weight 48 g | In distribution |
| 20046-006 | Weight 145 g | In distribution |
| 13060-025P | Weight 25 lb | In distribution |
| 07015-001P | Weight 6 lb | In distribution |
| 09029-048 | Weight 48 g | In distribution |
| 11042-048 | Weight 48 g | In distribution |
| 19008-002 | Weight 48 g | In distribution |
| 20039-006 | Weight 145 g | In distribution |
| 13041-048 | Weight 48 g | In distribution |
| 07014-006P | Weight 6 lb | In distribution |
| 07025-006P | Weight 6 lb | In distribution |
| A51-6P | Weight 6 lb | In distribution |
| 12016-001P | Weight 1 lb | In distribution |
| 07015-006P | Weight 6 lb | In distribution |
| 13090-006P | Weight 6 lb | In distribution |
| 13044-025P | Weight 25 lb | In distribution |
| 11071-006P | Weight 6 lb | In distribution |
| 11027-600P | Weight 145 g | In distribution |
| 11004-006P | Weight 6 lb | In distribution |
| 25160-001P | Weight 1 lb | In distribution |
| 11024-001P | Weight 1 lb | In distribution |
| 09041-006P | Weight 6 lb | In distribution |
| 11041-001P | Weight 1 lb | In distribution |
| 25110-001P | Weight 1 lb | In distribution |
| 07032-006P | Weight 6 lb | In distribution |
| 12031-048 | Weight 48 g | In distribution |
| 13095-048 | Weight 48 g | In distribution |
| 20035-016 | Weight 1 lb | In distribution |
| 07015-006 | Weight 145 g | In distribution |
| 11061-001P | Weight 1 lb | In distribution |
| A2-6P | Weight 6 lb | In distribution |
| 07016-025P | Weight 25 lb | In distribution |
| 08006-006 | Weight 145 g | In distribution |
| 09032-001P | Weight 1 lb | In distribution |
| 09003-006P | Weight 6 lb | In distribution |
| 20057-016 | Weight 1 lb | In distribution |
| 13031-048 | Weight 48 g | In distribution |
| 09037-001P | Weight 1 lb | In distribution |
| 07019-001P | Weight 1 lb | In distribution |
| 13031-006P | Weight 6 lb | In distribution |
| 12003-006P | Weight 6 lb | In distribution |
| 13029-006 | Weight 145 g | In distribution |
| 12003-001P | Weight 1 lb | In distribution |
| 13065-048 | Weight 48 g | In distribution |
| 13011-006P | Weight 6 lb | In distribution |
| 12017-048 | Weight 48 g | In distribution |
| 20013-016 | Weight 1 lb | In distribution |
| 11042-006P | Weight 6 lb | In distribution |
| 13044-006 | Weight 145 g | In distribution |
| 11028-001P | Weight 1 lb | In distribution |
| 10012-001P | Weight 1 lb | In distribution |
| 07025-025P | Weight 25 lb | In distribution |
| 05048-001P | Weight 1 lb | In distribution |
| 05070-600P | Weight 145 g | In distribution |
| 10012-006P | Weight 6 lb | In distribution |
| 13004-006P | Weight 6 lb | In distribution |
| 20016-006 | Weight 145 g | In distribution |
| 09028-001P | Weight 1 lb | In distribution |
| 20039-002 | Weight 48 g | In distribution |
| 07031-025P | Weight 25 lb | In distribution |
| 07015-048 | Weight 48 g | In distribution |
| 20041-002 | Weight 48 g | In distribution |
| 11026-001P | Weight 1 lb | In distribution |
| 25120-006P | Weight 6 lb | In distribution |
| 20052-006 | Weight 145 g | In distribution |
| 25180-001P | Weight 1 lb | In distribution |
| 07002-025P | Weight 25 lb | In distribution |
| 20044-006 | Weight 145 g | In distribution |
| 13022-006P | Weight 6 lb | In distribution |
| 07029-001P | Weight 1 lb | In distribution |
| 13041-006 | Weight 145 g | In distribution |
| 25014-006P | Weight 6 lb | In distribution |
| 13045-006P | Weight 6 lb | In distribution |
| 19016-002 | Weight 48 g | In distribution |
| 01041-006P | Weight 6 lb | In distribution |
| 13090-600P | Weight 145 g | In distribution |
| 08013-006P | Weight 6 lb | In distribution |
| 20046-002 | Weight 48 g | In distribution |
| 07035-001P | Weight 1 lb | In distribution |
| 13031-001P | Weight 1 lb | In distribution |
| 11037-001P | Weight 1 lb | In distribution |
| 07021-600P | Weight 145 g | In distribution |
| A49DP-6P | Weight 6 lb | In distribution |
| 09041-001P | Weight 1 lb | In distribution |
| 20047-002 | Weight 48 g | In distribution |
| 11046-001P | Weight 1 lb | In distribution |
| 12018-001P | Weight 1 lb | In distribution |
| 13095-006 | Weight 145 g | In distribution |
| 11037-048 | Weight 48 g | In distribution |
| 13039-006 | Weight 145 g | In distribution |
| 09002-001P | Weight 1 lb | In distribution |
| 07034-006P | Weight 6 lb | In distribution |
| 11042-001P | Weight 1 lb | In distribution |
| 05048-048 | Weight 48 g | In distribution |
| 08006-048 | Weight 48 g | In distribution |
| 07030-006 | Weight 48 g | In distribution |
| 20060-016 | Weight 1 lb | In distribution |
| 13042-006P | Weight 6 lb | In distribution |
| 20043-006 | Weight 145 g | In distribution |
| 11028-006P | Weight 6 lb | In distribution |
| 10019-001P | Weight 1 lb | In distribution |
| A1-6P | Weight 6 lb | In distribution |
| 20019-016 | Weight 1 lb | In distribution |
| 09027-006P | Weight 6 lb | In distribution |
| 11009-048 | Weight 48 g | In distribution |
| 07017-001P | Weight 1 lb | In distribution |
| 11005-001P | Weight 1 lb | In distribution |
| 07025-006 | Weight 145 g | In distribution |
| 07002-006P | Weight 6 lb | In distribution |
| 11025-600P | Weight 145 g | In distribution |
| 13030-006P | Weight 6 lb | In distribution |
| 09014-001P | Weight 1 lb | In distribution |
| 11068-006P | Weight 6 lb | In distribution |
| 09003-001P | Weight 1 lb | In distribution |
| 07021-025P | Weight 25 lb | In distribution |
| 07035-006P | Weight 6 lb | In distribution |
| 09020-006P | Weight 6 lb | In distribution |
| 11037-600P | Weight 145 g | In distribution |
| 09029-006P | Weight 6 lb | In distribution |
| 13038-025P | Weight 25 lb | In distribution |
| 20042-006 | Weight 145 g | In distribution |
| 11024-048 | Weight 48 g | In distribution |
| 07026-048 | Weight 48 g | In distribution |
| 11037-006P | Weight 6 lb | In distribution |
| 09020-025P | Weight 25 lb | In distribution |
| 13088-001P | Weight 1 lb | In distribution |
| 10016-006P | Weight 6 lb | In distribution |
| 13014-600P | Weight 145 g | In distribution |
| 13003-006P | Weight 6 lb | In distribution |
| 13041-001P | Weight 1 lb | In distribution |
| 09046-001P | Weight 1 lb | In distribution |
| 11032-006P | Weight 6 lb | In distribution |
| 09020-048 | Weight 48 g | In distribution |
| 11047-048 | Weight 48 g | In distribution |
| 07031-001P | Weight 1 lb | In distribution |
| 20040-016 | Weight 1 lb | In distribution |
| 09014-006P | Weight 6 lb | In distribution |
| 11025-001P | Weight 1 lb | In distribution |
| 10010-006P | Weight 6 lb | In distribution |
| 20032-002 | Weight 48 g | In distribution |
| 11031-001P | Weight 1 lb | In distribution |
| 20035-006 | Weight 145 g | In distribution |
| 11056-006P | Weight 6 lb | In distribution |
| 13010-001P | Weight 1 lb | In distribution |
| 07017-048 | Weight 48 g | In distribution |
| 13093-048 | Weight 48 g | In distribution |
| 11001-006P | Weight 6 lb | In distribution |
| 11047-001P | Weight 1 lb | In distribution |
| 11027-025P | Weight 25 lb | In distribution |
| 09031-001P | Weight 1 lb | In distribution |
| 11017-006P | Weight 6 lb | In distribution |
| 13065-001P | Weight 1 lb | In distribution |
| 13019-006P | Weight 6 lb | In distribution |
| 13044-001P | Weight 1 lb | In distribution |
| 11003-006P | Weight 6 lb | In distribution |
| 19031-006 | Weight 145 g | In distribution |
| 11009-001P | Weight 1 lb | In distribution |
| A5-6P | Weight 6 lb | In distribution |
| 11027-001P | Weight 1 lb | In distribution |
| 07030-006P | Weight 6 lb | In distribution |
| 08002-006P | Weight 6 lb | In distribution |
| 11058-006P | Weight 6 lb | In distribution |
| 13065-006P | Weight 6 lb | In distribution |
| 11008-048 | Weight 48 g | In distribution |
| 11017-001P | Weight 1 lb | In distribution |
| 11006-006P | Weight 6 lb | In distribution |
| 05070-006P | Weight 6 lb | In distribution |
| 07021-001P | Weight 1 lb | In distribution |
| 20032-006 | Weight 145 g | In distribution |
| 11001-001P | Weight 1 lb | In distribution |
| 04019-006P | Weight 6 lb | In distribution |
| 07030-006 | Weight 145 g | In distribution |
| 07001-048 | Weight 48 g | In distribution |
| 13094-001P | Weight 1 lb | In distribution |
| 07031-048 | Weight 48 g | In distribution |
| 07027-006P | Weight 6 lb | In distribution |
| 13030-006 | Weight 145 g | In distribution |
| 11027-006P | Weight 6 lb | In distribution |
| 10005-001P | Weight 1 lb | In distribution |
| 07031-006 | Weight 145 g | In distribution |
| 13011-001P | Weight 1 lb | In distribution |
| A51-25P | Weight 25 lb | In distribution |
| 13145-001P | Weight 1 lb | In distribution |
| 07026-006P | Weight 6 lb | In distribution |
| 11012-001P | Weight 1 lb | In distribution |
| 11032-048 | Weight 48 g | In distribution |
| 07015-025P | Weight 25 lb | In distribution |
| 07029-006P | Weight 6 lb | In distribution |
| 11046-048 | Weight 48 g | In distribution |
| 20009-006 | Weight 145 g | In distribution |
| 11024-006P | Weight 6 lb | In distribution |
| 13027-006P | Weight 1 lb | In distribution |
| 11050-006P | Weight 1 lb | In distribution |
| 10006-025P | Weight 25 lb | In distribution |
| 13030-025P | Weight 25 lb | In distribution |
| 10018-001P | Weight 1 lb | In distribution |
| 13145-006P | Weight 6 lb | In distribution |
| 25154-001P | Weight 1 lb | In distribution |
| A122-25P | Weight 6 lb | In distribution |
| 20025-002 | Weight 48 g | In distribution |
| 20044-016 | Weight 1 lb | In distribution |
| 13049-006P | Weight 6 lb | In distribution |
| 20032-016 | Weight 1 lb | In distribution |
| A52-6P | Weight 6 lb | In distribution |
| 20016-002 | Weight 48 g | In distribution |
| 09020-001P | Weight 1 lb | In distribution |
| 07027-006 | Weight 145 g | In distribution |
| 07019-600P | Weight 145 g | In distribution |
| 20042-002 | Weight 48 g | In distribution |
| 19013-016 | Weight 1 lb | In distribution |
| 20040-002 | Weight 48 g | In distribution |
| 11006-001P | Weight 1 lb | In distribution |
| 11046-600P | Weight 145 g | In distribution |
| A122-6P | Weight 6 lb | In distribution |
| 12005-001P | Weight 1 lb | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| 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 |
| 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.