Data / Medical devices / United States / J. Morita Usa, Inc.
J. Morita Usa, Inc.: FDA-registered device maker in Irvine, CA, United States, 10 510(k) clearances
J. Morita Usa, Inc. is registered with the FDA (registration 2081055) in Irvine, CA, United States. It lists 13 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 15, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2081055
- Address
- 9 Mason, Irvine, CA, United States, 92618
- Owner or operator
- J. MORITA USA (8030247)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- May 29, 2001
- Registered through
- 2027
- Brand names listed
- CB Temp Temporary Crown & Bridge Material, CF Carbon Fiber Post, FormCore DC Core Build-up Material, Foundation, Free Access II Lip & Cheek Retractor, GF Glass Fiber Post, Max Bond LC Self-etching Bonding Agent, Perfectim Systems and more
Devices it lists
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 15, 2022 | K220873 | Perceptive electric dental motor and control unit | EIA | Substantially Equivalent | Lares Research | accessdata.fda.gov |
| November 29, 2011 | K111087 | FOUNDATION | LYC | Substantially Equivalent | Olympus Terumo Biomaterials Corporation | accessdata.fda.gov |
| September 8, 2006 | K061664 | FORMCORE DC, MODEL 28-700100 | EBF | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| September 1, 2006 | K060882 | EXCEL BOND DC, MODEL 28-200100 | KLE | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| June 6, 2006 | K060844 | SILKLINE SOFT RELINING KIT, MODEL 28-100100 | EBI | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| May 17, 2002 | K012496 | CARBON POST | ELR | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| March 27, 2002 | K012849 | GLASS POST | ELR | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| March 7, 2002 | K020158 | NON-EUGENOL TEMPORARY CEMENT | EMB | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| March 4, 2002 | K020157 | TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| February 25, 1997 | K964692 | PERFECTIM | ELW | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
Compare with other makers
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- All makers of Accessories, Retractor, Dental
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Updated December 15, 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.