Esthet-X®HD High Definition Micro Matrix Restorative Compules Tips®
Esthet-X®HD High Definition Micro Matrix Restorative, White Opaque, 10 Compules® Tips Refill Package
10manufacturers in China registered for this device type
41catalogue numbers in this listing
32510(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 | Dentsply LLC, United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2024-02-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry. |
| Sizes | Weight 0.25 to 3 g; total volume 3 ml |
| Distribution end date | 2024-05-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 630619 | Weight 0.25 g | 20 | In distribution |
| 630633 | Weight 0.25 g | 20 | In distribution |
| 630631 | Esthet-X®HD Micro Matrix Restorative, D2, 10 Compules Tips Refill | 10 | In distribution |
| 630636 | Esthet-X®HD Micro Matrix Restorative, A4-O, 10 Compules Tips Refill | 10 | In distribution |
| 630626 | Weight 0.25 g | 10 | In distribution |
| 630630 | Weight 0.25 g | 10 | In distribution |
| 630616 | Esthet-X®HD Micro Matrix Restorative, XL, 10 Compules Tips Refill | 10 | In distribution |
| 630610 | Esthet-X®HD Micro Matrix Restorative, CE, 10 Compules Tips Refill | 10 | In distribution |
| 630640 | Weight 0.25 g | 10 | In distribution |
| 630638 | Weight 0.25 g | 10 | In distribution |
| 630622 | Weight 0.25 g | 20 | In distribution |
| 630632 | Esthet-X®HD Micro Matrix Restorative, D3, 10 Compules Tips Refill | 10 | In distribution |
| 630627 | Esthet-X®HD Micro Matrix Restorative, C2, 20 Compules® Tips Refill | 20 | In distribution |
| 630637 | Esthet-X®HD Micro Matrix Restorative, B2-O, 10 Compules Tips Refill | 10 | In distribution |
| 630629 | Weight 0.25 g | 10 | In distribution |
| 630635 | Weight 0.25 g | 10 | In distribution |
| 630614 | Esthet-X®HD Micro Matrix Restorative, GE, 10 Compules Tips Refill | 10 | In distribution |
| 630617 | Esthet-X®HD Micro Matrix Restorative, A1, 20 Compules® Tips Refill | 20 | In distribution |
| 630613 | Esthet-X®HD Micro Matrix Restorative, AE, 10 Compules Tips Refill | 10 | In distribution |
| 630620 | Esthet-X®HD Micro Matrix Restorative, A3.5, 20 Compules® Tips Refill | 20 | In distribution |
| 630615 | Esthet-X®HD Micro Matrix Restorative, White, 20 Compules® Tips Refill | 20 | In distribution |
| 630611 | Weight 0.25 g | 10 | In distribution |
| 630623 | Weight 0.25 g | 20 | In distribution |
| 630628 | Esthet-X®HD Micro Matrix Restorative, C3, 10 Compules Tips Refill | 10 | In distribution |
| 630624 | Weight 0.25 g | 10 | In distribution |
| 630612 | Esthet-X®HD Micro Matrix Restorative, YE, 10 Compules Tips Refill | 10 | In distribution |
| 630639 | Esthet-X®HD Micro Matrix Restorative, C4-O, 10 Compules Tips Refill | 10 | In distribution |
| 630625 | Esthet-X®HD Micro Matrix Restorative, B5-DY, 10 Compules Tips Refill | 10 | In distribution |
| 630634 | Weight 0.25 g | 10 | In distribution |
| 630618 | Weight 0.25 g | 20 | In distribution |
| 630621 | Weight 0.25 g | 10 | In distribution |
| 630604 | 20 Tips (0.25g) 5 of each shade: A1, A2, A2-0, YE, Enhance Finishers Sample, PoGo Polishers Sample, 1 Compules Tips Gun, 1 EsthetX HD Shade Tab A2 | Withdrawn | |
| 630601 | 60 Tips, 10 Unit Doses Adhesive, 1 Shade Guide, 1 Syringe Esthet-X®flow, Enhance Finishers Sample, PoGo Polishers Sample, 1 Syringe Tooth Conditioner Gel, 1 Tips Gun, Accessories | Withdrawn | |
| 630617B | Weight 0.25 g | 50 | Withdrawn |
| 630607 | Weight 0.25 g | Withdrawn | |
| 630711 | 31 Syringes (3 grams each) 1 of each shade: A1, A2, A3, A3.5, A4, B2, B3, C1, C2, C3, C4, C5, D2, D3, U, YE, AE, GE, CE, WE, W, XL, W-O, A2-O, A4-O, B2-O, C1-O, C4-O, D3-O | Withdrawn | |
| 630618B | Esthet-X®HD Micro Matrix Restorative, A2, 50 Compules Tips Refill | 50 | Withdrawn |
| 630600 | Weight 0.25 g | Withdrawn | |
| 630609 | Filled EsthetX HD compules®, Compules® Gun, Enhance® Disc, cup, and point; PoGo® II cup and point, and accessories | Withdrawn | |
| 630619B | Esthet-X®HD Micro Matrix Restorative, A3, 50 Compules Tips Refill | 50 | Withdrawn |
| 630714 | Weight 3 g | Withdrawn |
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 |
| 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 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K083841 | 2009-04-14 |
| K083326 | 2009-02-10 |
| K052097 | 2005-08-12 |
| K050880 | 2005-04-22 |
| K040144 | 2004-04-01 |
| K984387 | 1999-01-13 |
| K982318 | 1998-09-15 |
| K982395 | 1998-08-18 |
| K973221 | 1998-02-09 |
| K973235 | 1998-02-05 |
| K950991 | 1995-03-23 |
| K945769 | 1994-12-29 |
| K942031 | 1994-06-10 |
| K932395 | 1993-08-25 |
| K923236 | 1992-09-11 |
| K905476 | 1991-02-20 |
| K896564 | 1990-02-09 |
| K872907 | 1987-08-03 |
| K863552 | 1986-10-17 |
| K863174 | 1986-10-07 |
| K863092 | 1986-09-19 |
| K853431 | 1985-10-31 |
| K852659 | 1985-07-30 |
| K852658 | 1985-07-24 |
| K852151 | 1985-07-01 |
| K850911 | 1985-04-16 |
| K830442 | 1983-03-17 |
| K813357 | 1982-01-07 |
| K802975 | 1981-01-14 |
| K802125 | 1980-09-16 |
| K801732 | 1980-08-07 |
| K801092 | 1980-05-20 |
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.