G-Aenial™
G-aenial™ Sculpt Unitip Intro Kit, 20 unitips of each of (Shade A1, A2, & A3 only; 0.16mL each) & 1 G-Premio Bond Kit (5mL)
10manufacturers in China registered for this device type
225catalogue numbers in this listing
23510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| 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 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | GC America Inc., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K091388 |
| Record published | 2016-08-01 |
| 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 |
| Storage | Storage environment temperature 34 to 82 °F; Storage environment temperature 1 to 28 °C |
| Sizes | Total volume 1 to 2 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 004203 | Total Volume 2 ml | In distribution | |
| 012369 | Total Volume 1 ml | 2 | In distribution |
| 004202 | Total Volume 2 ml | In distribution | |
| 009168 | In distribution | ||
| 952258 | In distribution | ||
| 012375 | Total Volume 1 ml | 2 | In distribution |
| 009177 | 20 | In distribution | |
| 009183 | 10 | In distribution | |
| 012362 | 15 | In distribution | |
| 012371 | Total Volume 1 ml | 2 | In distribution |
| 009164 | In distribution | ||
| 952236 | In distribution | ||
| 952254 | In distribution | ||
| 004214 | Total Volume 2 ml | In distribution | |
| 004206 | Total Volume 2 ml | In distribution | |
| 952235 | In distribution | ||
| 008468 | Total Volume 2 ml | In distribution | |
| 012394 | Total Volume 2 ml | In distribution | |
| 009165 | In distribution | ||
| 008321 | Total Volume 2 ml | In distribution | |
| 009171 | 20 | In distribution | |
| 009162 | In distribution | ||
| 952233 | In distribution | ||
| 004208 | Total Volume 2 ml | In distribution | |
| 009177 | 20 | In distribution | |
| 008319 | Total Volume 2 ml | In distribution | |
| 012376 | Total Volume 1 ml | 2 | In distribution |
| 009175 | 20 | In distribution | |
| 012377 | Total Volume 1 ml | 2 | In distribution |
| 009159 | In distribution | ||
| 009176 | 20 | In distribution | |
| 004196 | Total Volume 2 ml | In distribution | |
| 009154 | In distribution | ||
| 004200 | Total Volume 2 ml | In distribution | |
| 009160 | In distribution | ||
| 009178 | 10 | In distribution | |
| 009159 | In distribution | ||
| 012379 | Total Volume 1 ml | 2 | In distribution |
| 009157 | In distribution | ||
| 952268 | In distribution | ||
| 009163 | In distribution | ||
| 012363 | 15 | In distribution | |
| 952232 | In distribution | ||
| 004194 | Total Volume 2 ml | In distribution | |
| 952252 | In distribution | ||
| 004204 | Total Volume 2 ml | In distribution | |
| 009170 | 20 | In distribution | |
| 008468 | Total Volume 2 ml | In distribution | |
| 009168 | In distribution | ||
| 009183 | 10 | In distribution | |
| 004208 | Total Volume 2 ml | In distribution | |
| 004195 | Total Volume 2 ml | In distribution | |
| 952256 | In distribution | ||
| 009180 | 10 | In distribution | |
| 008322 | Total Volume 2 ml | In distribution | |
| 009178 | 10 | In distribution | |
| 012355 | 15 | In distribution | |
| 952245 | In distribution | ||
| 012378 | Total Volume 1 ml | 2 | In distribution |
| 952248 | In distribution | ||
| 012366 | Total Volume 1 ml | 2 | In distribution |
| 004197 | Total Volume 2 ml | In distribution | |
| 012353 | 15 | In distribution | |
| 401100 | 20 | In distribution | |
| 952263 | In distribution | ||
| 004634 | 30 | In distribution | |
| 012374 | Total Volume 1 ml | 2 | In distribution |
| 008323 | Total Volume 2 ml | In distribution | |
| 009182 | 10 | In distribution | |
| 008324 | Total Volume 2 ml | In distribution | |
| 004216 | Total Volume 2 ml | In distribution | |
| 012372 | Total Volume 1 ml | 2 | In distribution |
| 004214 | Total Volume 2 ml | In distribution | |
| 952241 | In distribution | ||
| 008324 | Total Volume 2 ml | In distribution | |
| 009155 | In distribution | ||
| 952237 | In distribution | ||
| 009160 | In distribution | ||
| 009158 | In distribution | ||
| 008318 | Total Volume 2 ml | In distribution | |
| 008320 | Total Volume 2 ml | In distribution | |
| 009185 | 10 | In distribution | |
| 009169 | 20 | In distribution | |
| 009166 | In distribution | ||
| 012364 | Total Volume 1 ml | 2 | In distribution |
| 012373 | Total Volume 1 ml | 2 | In distribution |
| 009161 | In distribution | ||
| 009176 | 20 | In distribution | |
| 009172 | 20 | In distribution | |
| 012368 | Total Volume 1 ml | 2 | In distribution |
| 012378 | Total Volume 1 ml | 2 | In distribution |
| 008318 | Total Volume 2 ml | In distribution | |
| 004199 | Total Volume 2 ml | In distribution | |
| 004198 | Total Volume 2 ml | In distribution | |
| 012360 | 15 | In distribution | |
| 004635 | 30 | In distribution | |
| 952257 | In distribution | ||
| 004635 | 30 | In distribution | |
| 952250 | In distribution | ||
| 009157 | In distribution | ||
| 008317 | Total Volume 2 ml | In distribution | |
| 004201 | Total Volume 2 ml | In distribution | |
| 009156 | In distribution | ||
| 012352 | 15 | In distribution | |
| 952230 | In distribution | ||
| 004634 | 30 | In distribution | |
| 012368 | Total Volume 1 ml | 2 | In distribution |
| 952239 | In distribution | ||
| 009166 | In distribution | ||
| 004201 | Total Volume 2 ml | In distribution | |
| 012379 | Total Volume 1 ml | 2 | In distribution |
| 009169 | 20 | In distribution | |
| 952243 | In distribution | ||
| 004206 | Total Volume 2 ml | In distribution | |
| 952260 | In distribution | ||
| 009155 | In distribution | ||
| 009167 | In distribution | ||
| 009181 | 10 | In distribution | |
| 012359 | 15 | In distribution | |
| 004197 | Total Volume 2 ml | In distribution | |
| 952240 | In distribution | ||
| 004215 | Total Volume 2 ml | In distribution | |
| 009167 | In distribution | ||
| 012374 | Total Volume 1 ml | 2 | In distribution |
| 009153 | In distribution | ||
| 009179 | 10 | In distribution | |
| 004200 | Total Volume 2 ml | In distribution | |
| 012375 | Total Volume 1 ml | 2 | In distribution |
| 012376 | Total Volume 1 ml | 2 | In distribution |
| 004212 | Total Volume 2 ml | In distribution | |
| 004209 | Total Volume 2 ml | In distribution | |
| 009164 | In distribution | ||
| 009170 | 20 | In distribution | |
| 004198 | Total Volume 2 ml | In distribution | |
| 012356 | 15 | In distribution | |
| 004210 | Total Volume 2 ml | In distribution | |
| 004196 | Total Volume 2 ml | In distribution | |
| 009173 | 20 | In distribution | |
| 009179 | 10 | In distribution | |
| 952262 | In distribution | ||
| 012357 | 15 | In distribution | |
| 008321 | Total Volume 2 ml | In distribution | |
| 012370 | Total Volume 1 ml | 2 | In distribution |
| 952255 | In distribution | ||
| 004194 | Total Volume 2 ml | In distribution | |
| 009153 | In distribution | ||
| 012351 | 15 | In distribution | |
| 004202 | Total Volume 2 ml | In distribution | |
| 004195 | Total Volume 2 ml | In distribution | |
| 004213 | Total Volume 2 ml | In distribution | |
| 952251 | In distribution | ||
| 009152 | In distribution | ||
| 004211 | Total Volume 2 ml | In distribution | |
| 012377 | Total Volume 1 ml | 2 | In distribution |
| 952238 | In distribution | ||
| 012373 | Total Volume 1 ml | 2 | In distribution |
| 012348 | 15 | In distribution | |
| 008317 | Total Volume 2 ml | In distribution | |
| 008319 | Total Volume 2 ml | In distribution | |
| 004207 | Total Volume 2 ml | In distribution | |
| 009181 | 10 | In distribution | |
| 004204 | Total Volume 2 ml | In distribution | |
| 004213 | Total Volume 2 ml | In distribution | |
| 009182 | 10 | In distribution | |
| 012281 | 20 | In distribution | |
| 009184 | 10 | In distribution | |
| 004210 | Total Volume 2 ml | In distribution | |
| 012394 | Total Volume 2 ml | In distribution | |
| 008322 | Total Volume 2 ml | In distribution | |
| 952231 | In distribution | ||
| 004205 | Total Volume 2 ml | In distribution | |
| 012358 | 15 | In distribution | |
| 012365 | Total Volume 1 ml | 2 | In distribution |
| 401000 | In distribution | ||
| 952247 | In distribution | ||
| 004215 | Total Volume 2 ml | In distribution | |
| 009180 | 10 | In distribution | |
| 009161 | In distribution | ||
| 952259 | In distribution | ||
| 009172 | 20 | In distribution | |
| 004211 | Total Volume 2 ml | In distribution | |
| 012369 | Total Volume 1 ml | 2 | In distribution |
| 009158 | In distribution | ||
| 012367 | Total Volume 1 ml | 2 | In distribution |
| 952253 | In distribution | ||
| 009174 | 20 | In distribution | |
| 009163 | In distribution | ||
| 012395 | Total Volume 2 ml | In distribution | |
| 012372 | Total Volume 1 ml | 2 | In distribution |
| 009174 | 20 | In distribution | |
| 952242 | In distribution | ||
| 012354 | 15 | In distribution | |
| 952234 | In distribution | ||
| 012371 | Total Volume 1 ml | 2 | In distribution |
| 952264 | In distribution | ||
| 004207 | Total Volume 2 ml | In distribution | |
| 952267 | In distribution | ||
| 004205 | Total Volume 2 ml | In distribution | |
| 009171 | 20 | In distribution | |
| 012349 | 15 | In distribution | |
| 009162 | In distribution | ||
| 012281 | 20 | In distribution | |
| 952246 | In distribution | ||
| 952244 | In distribution | ||
| 004209 | Total Volume 2 ml | In distribution | |
| 012370 | Total Volume 1 ml | 2 | In distribution |
| 009175 | 20 | In distribution | |
| 009152 | In distribution | ||
| 952249 | In distribution | ||
| 004199 | Total Volume 2 ml | In distribution | |
| 009154 | In distribution | ||
| 009156 | In distribution | ||
| 008323 | Total Volume 2 ml | In distribution | |
| 004203 | Total Volume 2 ml | In distribution | |
| 012364 | Total Volume 1 ml | 2 | In distribution |
| 012350 | 15 | In distribution | |
| 009165 | In distribution | ||
| 004212 | Total Volume 2 ml | In distribution | |
| 012361 | 15 | In distribution | |
| 009184 | 10 | In distribution | |
| 004216 | Total Volume 2 ml | In distribution | |
| 009185 | 10 | In distribution | |
| 009173 | 20 | In distribution | |
| 008320 | Total Volume 2 ml | In distribution | |
| 012395 | Total Volume 2 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
| IPS Empress Direct | Ivoclar Vivadent Aktiengesellschaft | 147 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261246 | 2026-06-18 |
| K251946 | 2025-08-29 |
| K192260 | 2019-11-22 |
| K173500 | 2018-03-08 |
| K153325 | 2016-07-12 |
| K153127 | 2016-05-20 |
| K151541 | 2015-10-09 |
| K133182 | 2014-04-09 |
| K133824 | 2014-03-14 |
| K123631 | 2013-07-23 |
| K091388 | 2009-07-22 |
| K090747 | 2009-06-10 |
| K082434 | 2008-11-14 |
| K082171 | 2008-10-30 |
| K080478 | 2008-06-05 |
| K070190 | 2007-03-12 |
| K042348 | 2004-11-18 |
| K033808 | 2004-02-02 |
| K023814 | 2003-01-30 |
| K020342 | 2002-03-28 |
| K001518 | 2000-07-05 |
| K993973 | 2000-01-11 |
| K942993 | 1995-02-07 |
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.