Data / Medical devices / United States / Opa Dental, LLC
Opa Dental, LLC: FDA-registered device maker in Huntington, WV, United States, 12 510(k) clearances
Opa Dental, LLC is registered with the FDA (registration 3008582406) in Huntington, WV, United States. It lists 13 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 12, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008582406
- Address
- 105 Whitaker blvd, Huntington, WV, United States, 25701
- Owner or operator
- Opa Dental, LLC (10033786)
- Roles
- Repackager or relabeler
- First device listed
- August 7, 2013
- Registered through
- 2026
- Brand names listed
- Ceramic grinder, Rubber polisher, Silicone polisher, diamond burs
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bur, Dental | EJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wheel, Polishing Agent | EJQ | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 12, 2022 | K221510 | TrusFIL-Flow Flowable Composite Restorative | EBF | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| January 7, 2022 | K213570 | Dental Zirconia Ceramic | EIH | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. | accessdata.fda.gov |
| October 6, 2021 | K202063 | TrusFIL Universal Composite Restorative | EBF | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| December 17, 2020 | K190217 | Aidite PMMA | EBG | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. | accessdata.fda.gov |
| September 29, 2020 | K201790 | Dual Cure Resin Cement | EMA | Substantially Equivalent | Rizhao Huge Biomaterials Company, Ltd. | accessdata.fda.gov |
| September 24, 2020 | K201684 | A-Silicone for Bite Registration | ELW | Substantially Equivalent | Shandong Huge Dental Material Corporation | accessdata.fda.gov |
| September 2, 2018 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| December 4, 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| February 9, 2015 | K141421 | PMMA BLOCK | EBG | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. | accessdata.fda.gov |
| October 22, 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| October 22, 2014 | K141723 | UPCERA COLORING LIQUID (I AND II ) | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| May 28, 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Syringe, Restorative And Impression Material
- All makers of Bur, Dental
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Wax, Dental, Intraoral
- All makers of Tray, Impression, Preformed
Updated October 12, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.