Data / Medical devices / United States / Meta Dental Corp.
Meta Dental Corp.: FDA-registered device maker in Glendale, NY, United States, 12 510(k) clearances
Meta Dental Corp. is registered with the FDA (registration 2436986) in Glendale, NY, United States. It lists 13 device types. The FDA files 12 510(k) clearances under its listings, the newest dated December 4, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2436986
- FEI number
- 3000206706
- Address
- 73-15 88th Street, Glendale, NY, United States, 11385
- Owner or operator
- META DENTAL CORP. (9011417)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- February 19, 2010
- Registered through
- 2026
- Brand names listed
- ABRASIVE STONE POINT, AdSeal Root Canal Sealer, Articulator, BLADE, SCALPEL, Gutta Percha Point, IMPRESSION TRAY, MD Cleanser, Md-Temp and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Articulators | EJP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | 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 |
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 |
|---|---|---|---|---|---|---|
| December 4, 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| December 18, 2014 | K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) | EIH | Substantially Equivalent | Liaoning Upcera 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 |
| February 12, 2010 | K093208 | SIMPLISEAL | KIF | Substantially Equivalent | Discus Dental, LLC | accessdata.fda.gov |
| January 28, 2010 | K093560 | UPCERA ZIRCONIA BLANKS | EIH | Substantially Equivalent | Shenyang Upcera Co., Ltd. | accessdata.fda.gov |
| March 26, 2007 | K070045 | ZIRBLANK-PS AND ZIRBLANK-FS | EIH | Substantially Equivalent | Acucera, Inc. | accessdata.fda.gov |
| July 21, 2006 | K061530 | MD-TEMP | EBG | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| October 19, 2005 | K051501 | ZIRACE | NHA | Substantially Equivalent | Acucera, Inc. | accessdata.fda.gov |
| November 24, 2004 | K042769 | ADSEAL ROOT CANAL SEALER | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| October 8, 2003 | K032605 | METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| October 7, 2003 | K032603 | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Resin, Root Canal Filling
- All makers of Articulators
- All makers of Wax, Dental, Intraoral
- All makers of Blade, Scalpel
- All makers of Abutment, Implant, Dental, Endosseous
Updated December 4, 2015. 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.