Gradia®
GRADIA PLUS is a light-cured dental composite made from cross-linked polymeric material reinforced with filler particles bonded to a resin matrix. The filing says a photoinitiator allows…
GRADIA PLUS is a light-cured dental composite made from cross-linked polymeric material reinforced with filler particles bonded to a resin matrix. The filing says a photoinitiator allows the material to cure from paste into a hard solid.
The FDA indications include crown and bridgework with metal backing, jacket crowns, inlays, onlays, laminated veneers, implant superstructures and reproduction of gum tissue for crown restorations.
Listed Item
GRADIA® gum Starter Package Contains: Two opaques (2.4 mL syringes), 4 shades (2.9 mL syringes), 1 translucent (2.4 mL syringe), 1 disposable palette, 1 light protective cover, 1 mixing pad, #7 brush, 1 Shade Guide Kit and 1 Color Chart.
Dental Applications
The filing describes GRADIA PLUS as supplied in a syringe and identifies a light-cured, nano-filled radiopaque composite resin. It also describes use in the listed restorative applications; the submission does not establish patient outcomes.
10manufacturers in China registered for this device type
548catalogue 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) | K153325 |
| Record published | 2021-09-01 |
| Record revised | 2020-06-19 (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 |
| Storage | Storage environment temperature 39 to 77 °F; Storage environment temperature 4 to 25 °C |
| Packaging | Carton of 5 |
| Sizes | Total volume 0.16 to 3 ml; weight 1.3 to 8 g |
| Distribution end date | 2020-06-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 901089 | In distribution | ||
| 003651 | In distribution | ||
| 001487 | In distribution | ||
| 901097 | In distribution | ||
| 901056 | In distribution | ||
| 002053 | Total Volume 2.4 ml | In distribution | |
| 001420 | In distribution | ||
| 901114 | In distribution | ||
| 001420 | In distribution | ||
| 002043 | Total Volume 2.4 ml | In distribution | |
| 901092 | In distribution | ||
| 001927 | 20 | In distribution | |
| 002298 | Weight 1.3 g | In distribution | |
| 001972 | Total Volume 0.16 ml | 20 | In distribution |
| 001425 | In distribution | ||
| 002278 | Weight 1.5 g | In distribution | |
| 001448 | In distribution | ||
| 901082 | In distribution | ||
| 001511 | In distribution | ||
| 001503 | In distribution | ||
| 001975 | Total Volume 0.16 ml | 20 | In distribution |
| 001908 | Weight 1.4 g | In distribution | |
| 002605 | Total Volume 2.7 ml | In distribution | |
| 001967 | Total Volume 0.16 ml | 20 | In distribution |
| 001901 | Total Volume 2.4 ml | In distribution | |
| 001497 | In distribution | ||
| 001899 | Total Volume 2.4 ml | In distribution | |
| 002358 | Weight 1.5 g | In distribution | |
| 001499 | In distribution | ||
| 001987 | Total Volume 0.16 ml | 10 | In distribution |
| 003652 | In distribution | ||
| 901059 | In distribution | ||
| 001905 | Total Volume 2.4 ml | In distribution | |
| 002602 | Total Volume 2.7 ml | In distribution | |
| 001455 | In distribution | ||
| 002000 | Total Volume 0.16 ml | 20 | In distribution |
| 001898 | Total Volume 2.9 ml | In distribution | |
| 001979 | Total Volume 0.16 ml | 10 | In distribution |
| 002296 | Weight 1.3 g | In distribution | |
| 001437 | In distribution | ||
| 901136 | 10 | In distribution | |
| 001436 | In distribution | ||
| 001431 | In distribution | ||
| 001902 | Total Volume 2.4 ml | In distribution | |
| 400010 | In distribution | ||
| 001982 | Total Volume 0.16 ml | 10 | In distribution |
| 001890 | Total Volume 2.4 ml | In distribution | |
| 901105 | In distribution | ||
| 001479 | In distribution | ||
| 002600 | Total Volume 0.16 ml | 10 | In distribution |
| 001422 | In distribution | ||
| 001450 | In distribution | ||
| 001439 | In distribution | ||
| 001980 | Total Volume 0.16 ml | 10 | In distribution |
| 001894 | Total Volume 2.9 ml | In distribution | |
| 901102 | In distribution | ||
| 001491 | In distribution | ||
| 001457 | In distribution | ||
| 001421 | In distribution | ||
| 002041 | Total Volume 0.16 ml | 20 | In distribution |
| 002440 | In distribution | ||
| 001983 | Total Volume 0.16 ml | 10 | In distribution |
| 002279 | Weight 1.5 g | In distribution | |
| 001478 | In distribution | ||
| 001432 | In distribution | ||
| 001454 | In distribution | ||
| 002594 | Total Volume 0.16 ml | 20 | In distribution |
| 001480 | In distribution | ||
| 001438 | In distribution | ||
| 001492 | In distribution | ||
| 901069 | In distribution | ||
| 002273 | Total Volume 0.16 ml | 10 | In distribution |
| 901094 | In distribution | ||
| 001484 | In distribution | ||
| 002601 | Total Volume 2.7 ml | In distribution | |
| 002599 | Total Volume 0.16 ml | 10 | In distribution |
| 002609 | In distribution | ||
| 002285 | Weight 1.5 g | In distribution | |
| 001976 | Total Volume 0.16 ml | 10 | In distribution |
| 001997 | Total Volume 0.16 ml | 20 | In distribution |
| 001899 | Total Volume 2.4 ml | In distribution | |
| 002590 | Total Volume 0.16 ml | 20 | In distribution |
| 002275 | Total Volume 2.4 ml | In distribution | |
| 002593 | Total Volume 0.16 ml | 20 | In distribution |
| 002436 | In distribution | ||
| 001897 | Total Volume 2.9 ml | In distribution | |
| 901066 | In distribution | ||
| 002295 | Weight 1.3 g | In distribution | |
| 002592 | Total Volume 0.16 ml | 20 | In distribution |
| 901057 | In distribution | ||
| 002055 | Total Volume 2.7 ml | In distribution | |
| 901130 | In distribution | ||
| 002292 | Weight 1.3 g | In distribution | |
| 001438 | In distribution | ||
| 002051 | Total Volume 2.4 ml | In distribution | |
| 001451 | In distribution | ||
| 002796 | Total Volume 2.7 ml | In distribution | |
| 002598 | Total Volume 0.16 ml | 10 | In distribution |
| 001987 | Total Volume 0.16 ml | 10 | In distribution |
| 001478 | In distribution | ||
| 001891 | Total Volume 2.4 ml | In distribution | |
| 001972 | Total Volume 0.16 ml | 20 | In distribution |
| 001495 | In distribution | ||
| 001446 | In distribution | ||
| 001433 | In distribution | ||
| 002436 | In distribution | ||
| 002278 | Weight 1.5 g | In distribution | |
| 901131 | In distribution | ||
| 001990 | Total Volume 2.4 ml | In distribution | |
| 001901 | Total Volume 2.4 ml | In distribution | |
| 001467 | In distribution | ||
| 002281 | Weight 1.5 g | In distribution | |
| 001982 | Total Volume 0.16 ml | 10 | In distribution |
| 400011 | In distribution | ||
| 002049 | Total Volume 2.4 ml | In distribution | |
| 002607 | Total Volume 2.7 ml | In distribution | |
| 001447 | In distribution | ||
| 001971 | Total Volume 0.16 ml | 20 | In distribution |
| 001486 | In distribution | ||
| 002044 | Total Volume 2.4 ml | In distribution | |
| 901127 | In distribution | ||
| 001991 | Total Volume 2.4 ml | In distribution | |
| 002795 | Total Volume 2.7 ml | In distribution | |
| 002005 | Total Volume 2.7 ml | In distribution | |
| 001455 | In distribution | ||
| 901070 | In distribution | ||
| 001484 | In distribution | ||
| 001452 | In distribution | ||
| 901071 | In distribution | ||
| 901108 | In distribution | ||
| 001501 | In distribution | ||
| 001496 | In distribution | ||
| 901052 | In distribution | ||
| 001985 | Total Volume 0.16 ml | 10 | In distribution |
| 001475 | In distribution | ||
| 001511 | In distribution | ||
| 002008 | Total Volume 2.7 ml | In distribution | |
| 001509 | In distribution | ||
| 001428 | In distribution | ||
| 001508 | In distribution | ||
| 901101 | In distribution | ||
| 001970 | Total Volume 0.16 ml | 20 | In distribution |
| 001462 | In distribution | ||
| 001986 | Total Volume 0.16 ml | 10 | In distribution |
| 901073 | In distribution | ||
| 001446 | In distribution | ||
| 002598 | Total Volume 0.16 ml | 10 | In distribution |
| 001482 | In distribution | ||
| 001513 | In distribution | ||
| 002597 | Total Volume 0.16 ml | 10 | In distribution |
| 001477 | In distribution | ||
| 001500 | In distribution | ||
| 001436 | In distribution | ||
| 001502 | In distribution | ||
| 901058 | In distribution | ||
| 901117 | In distribution | ||
| 901085 | In distribution | ||
| 001431 | In distribution | ||
| 001477 | In distribution | ||
| 001501 | In distribution | ||
| 001483 | In distribution | ||
| 001904 | Total Volume 2.4 ml | In distribution | |
| 001474 | In distribution | ||
| 001487 | In distribution | ||
| 901107 | In distribution | ||
| 002042 | Total Volume 2.4 ml | In distribution | |
| 001440 | In distribution | ||
| 002441 | In distribution | ||
| 901103 | In distribution | ||
| 001435 | In distribution | ||
| 001453 | In distribution | ||
| 001460 | In distribution | ||
| 001992 | Total Volume 2.4 ml | In distribution | |
| 001500 | In distribution | ||
| 001505 | In distribution | ||
| 001528 | In distribution | ||
| 002441 | In distribution | ||
| 901096 | In distribution | ||
| 001482 | In distribution | ||
| 901072 | In distribution | ||
| 001459 | In distribution | ||
| 901104 | In distribution | ||
| 001463 | In distribution | ||
| 001481 | In distribution | ||
| 002593 | Total Volume 0.16 ml | 20 | In distribution |
| 001464 | In distribution | ||
| 002596 | Total Volume 0.16 ml | 10 | In distribution |
| 001997 | Total Volume 0.16 ml | 20 | In distribution |
| 001427 | In distribution | ||
| 001505 | In distribution | ||
| 001483 | In distribution | ||
| 001475 | In distribution | ||
| 001485 | In distribution | ||
| 001986 | Total Volume 0.16 ml | 10 | In distribution |
| 002290 | Weight 1.3 g | In distribution | |
| 001469 | In distribution | ||
| 901121 | In distribution | ||
| 901064 | In distribution | ||
| 901084 | In distribution | ||
| 901116 | In distribution | ||
| 002611 | Total Volume 2.7 ml | In distribution | |
| 901098 | In distribution | ||
| 001996 | Total Volume 2.4 ml | In distribution | |
| 001445 | In distribution | ||
| 901090 | In distribution | ||
| 901106 | In distribution | ||
| 002040 | Total Volume 0.16 ml | 20 | In distribution |
| 001480 | In distribution | ||
| 001503 | In distribution | ||
| 002610 | In distribution | ||
| 002003 | Total Volume 2.7 ml | In distribution | |
| 001490 | In distribution | ||
| 001430 | In distribution | ||
| 001469 | In distribution | ||
| 002599 | Total Volume 0.16 ml | 10 | In distribution |
| 002601 | Total Volume 2.7 ml | In distribution | |
| 001498 | In distribution | ||
| 001426 | In distribution | ||
| 001967 | Total Volume 0.16 ml | 20 | In distribution |
| 001889 | In distribution | ||
| 002596 | Total Volume 0.16 ml | 10 | In distribution |
| 001969 | Total Volume 0.16 ml | 20 | In distribution |
| 002284 | Weight 1.5 g | In distribution | |
| 001926 | 20 | In distribution | |
| 002610 | In distribution | ||
| 002437 | In distribution | ||
| 001892 | Total Volume 2.4 ml | In distribution | |
| 001516 | Weight 8 g | In distribution | |
| 901124 | In distribution | ||
| 002045 | Total Volume 2.4 ml | In distribution | |
| 001502 | In distribution | ||
| 001434 | In distribution | ||
| 001927 | 20 | In distribution | |
| 002602 | Total Volume 2.7 ml | In distribution | |
| 001449 | In distribution | ||
| 901063 | In distribution | ||
| 001461 | In distribution | ||
| 001506 | In distribution | ||
| 001488 | In distribution | ||
| 001498 | In distribution | ||
| 002042 | Total Volume 2.4 ml | In distribution | |
| 002050 | Total Volume 2.4 ml | In distribution | |
| 002274 | Total Volume 2.4 ml | In distribution | |
| 002044 | Total Volume 2.4 ml | In distribution | |
| 901099 | In distribution | ||
| 001506 | In distribution | ||
| 001977 | Total Volume 0.16 ml | 10 | In distribution |
| 002281 | Weight 1.5 g | In distribution | |
| 001889 | In distribution | ||
| 901048 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| 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.