Axcent Acrylics
Standard DNT Base Purp Fiber HC (1# Each)
14manufacturers in China registered for this device type
132catalogue 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 | Garreco, LLC, United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2016-09-25 |
| Record revised | 2021-11-10 (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 |
| Packaging | Pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3845030 | In distribution | |
| 3730201 | In distribution | |
| 3738001 | In distribution | |
| 3018020 | In distribution | |
| 3103401 | In distribution | |
| 3910030 | In distribution | |
| 3010120 | In distribution | |
| 3750920 | In distribution | |
| 3760120 | In distribution | |
| 3010305 | In distribution | |
| 3108801 | In distribution | |
| 3860004 | In distribution | |
| 3738805 | In distribution | |
| 3738005 | In distribution | |
| 3760125 | In distribution | |
| 3108005 | In distribution | |
| 3780004 | In distribution | |
| 3010105 | In distribution | |
| 3108001 | In distribution | |
| 3830004 | In distribution | |
| 3010101 | In distribution | |
| 3766305 | In distribution | |
| 3018801 | In distribution | |
| 3100205 | In distribution | |
| 3733401 | In distribution | |
| 3708005 | In distribution | |
| 3780008 | In distribution | |
| 3910008 | In distribution | |
| 3700405 | In distribution | |
| 3730120 | In distribution | |
| 3103405 | In distribution | |
| 3100425 | In distribution | |
| 3830030 | In distribution | |
| 3750905 | In distribution | |
| 3700201 | In distribution | |
| 3750220 | In distribution | |
| 3100320 | In distribution | |
| 3108805 | In distribution | |
| 3845008 | In distribution | |
| 3010405 | In distribution | |
| 8601020 | In distribution | |
| 3730205 | In distribution | |
| 3750201 | In distribution | |
| 3108820 | In distribution | |
| 3860030 | In distribution | |
| 3700205 | In distribution | |
| 3738825 | In distribution | |
| 3738801 | In distribution | |
| 3733405 | In distribution | |
| 3108825 | In distribution | |
| 3018805 | In distribution | |
| 3700420 | In distribution | |
| 3708801 | In distribution | |
| 3750901 | In distribution | |
| 3100125 | In distribution | |
| 3750205 | In distribution | |
| 3760105 | In distribution | |
| 3733420 | In distribution | |
| 3700320 | In distribution | |
| 3730101 | In distribution | |
| 3703405 | In distribution | |
| 3100201 | In distribution | |
| 3013405 | In distribution | |
| 3700220 | In distribution | |
| 3708020 | In distribution | |
| 3703401 | In distribution | |
| 3763005 | In distribution | |
| 3730105 | In distribution | |
| 3708025 | In distribution | |
| 3910004 | In distribution | |
| 3738820 | In distribution | |
| 3766304 | In distribution | |
| 3700120 | In distribution | |
| 3100105 | In distribution | |
| 3010205 | In distribution | |
| 8601060 | In distribution | |
| 3730405 | In distribution | |
| 3700101 | In distribution | |
| 3800008 | In distribution | |
| 3760101 | In distribution | |
| 3010320 | In distribution | |
| 3103420 | In distribution | |
| 3013401 | In distribution | |
| 3108025 | In distribution | |
| 3800030 | In distribution | |
| 3766301 | In distribution | |
| 3738020 | In distribution | |
| 8601040 | In distribution | |
| 3010201 | In distribution | |
| 3018820 | In distribution | |
| 3100420 | In distribution | |
| 3100220 | In distribution | |
| 3010425 | In distribution | |
| 3700301 | In distribution | |
| 8601030 | In distribution | |
| 3018001 | In distribution | |
| 3700401 | In distribution | |
| 3730225 | In distribution | |
| 3100301 | In distribution | |
| 3763020 | In distribution | |
| 3013420 | In distribution | |
| 3100120 | In distribution | |
| 3700305 | In distribution | |
| 3730420 | In distribution | |
| 3010301 | In distribution | |
| 3708805 | In distribution | |
| 3700105 | In distribution | |
| 3708820 | In distribution | |
| 3766320 | In distribution | |
| 3010225 | In distribution | |
| 3763004 | In distribution | |
| 3703420 | In distribution | |
| 3010420 | In distribution | |
| 3100225 | In distribution | |
| 3010220 | In distribution | |
| 3860008 | In distribution | |
| 3100101 | In distribution | |
| 3763001 | In distribution | |
| 8601050 | In distribution | |
| 3760104 | In distribution | |
| 8601010 | In distribution | |
| 3780030 | In distribution | |
| 3100305 | In distribution | |
| 3100405 | In distribution | |
| 3708001 | In distribution | |
| 3730220 | In distribution | |
| 3730401 | In distribution | |
| 3010401 | In distribution | |
| 3108020 | In distribution | |
| 3018005 | In distribution | |
| 3100401 | In distribution | |
| 3830008 | 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 |
| 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.