Registered with FDA
Opa Dental, LLC
Huntington, WV, United States. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Opa Dental, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | — | 2015 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2021 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2015 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2018 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | — | 2018 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | — | 2021 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | — | 2013 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | — | 2013 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | — | 2018 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | — | 2018 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | diamond burs | 2013 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Lister | Ceramic grinderRubber polisherSilicone polisher | 2013 |
| Dental CementEMA · Class 2 | Dental cements | Lister | — | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Opa Dental, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Liaoning Upcera Co., Ltd (4), Rizhao HuGe Biomaterials Company, Ltd. (3), Aidite (Qinhuangdao) Technology Co., Ltd (2), Shandong Huge Dental Material Corporation (1), Rizhao Huge Dental Industry Co., Ltd. (1), Rizhao Huge Dental Industry Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 Oct 2022 | K221510 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF Resin Tooth Shade Material |
| 7 Jan 2022 | K213570 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd | EIH Porcelain Powder |
| 6 Oct 2021 | K202063 | TrusFIL Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF Resin Tooth Shade Material |
| 17 Dec 2020 | K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd | EBG Resin Temporary Crown and Bridge |
| 29 Sep 2020 | K201790 | Dual Cure Resin Cement | Rizhao HuGe Biomaterials Company, Ltd. | EMA Dental Cement |
| 24 Sep 2020 | K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | ELW Impression Material |
| 2 Sep 2018 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 4 Dec 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 9 Feb 2015 | K141421 | PMMA BLOCK | Rizhao Huge Dental Industry Co., Ltd. | EBG Resin Temporary Crown and Bridge |
| 22 Oct 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 22 Oct 2014 | K141723 | UPCERA COLORING LIQUID (I AND II ) | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 28 May 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | Rizhao Huge Dental Industry Co., Ltd. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OPA DENTAL, LLCFDA reg. 3008582406 | Huntington, WV, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033786). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.