Data / Medical devices / United States / Olson Global Laboratory
Olson Global Laboratory: FDA-registered device maker in Clinton Township, MI, United States, 5 510(k) clearances
Olson Global Laboratory is registered with the FDA (registration 3005344553) in Clinton Township, MI, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 31, 2007. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005344553
- Address
- 16404 19 Mile Rd, Clinton Township, MI, United States, 48038
- Owner or operator
- Olson Dental Laboratory, Inc. (9077241)
- Roles
- Repackager or relabeler
- First device listed
- January 14, 2013
- Registered through
- 2026
- Brand names listed
- Alloy, Base Metal, Alloy, Gold based noble metal, Duracetal, Powder, Porcelain, Teeth, acrylic, resin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Gold-Based Noble Metal | EJT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Clasp, Preformed | EHP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | 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 31, 2007 | K072569 | METOXIT CAM-BLANKS | EIH | Substantially Equivalent | Metoxit AG | accessdata.fda.gov |
| April 7, 2006 | K060507 | VALPLAST YAMAHACHI TEETH | ELM | Substantially Equivalent | Valplast Intl. Corp. | accessdata.fda.gov |
| July 7, 2005 | K051358 | NATURE-CRYL HI PLUS | EBI | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| August 29, 2002 | K022032 | ACETAL | EHP | Substantially Equivalent | Inovativ, LLC | accessdata.fda.gov |
| October 6, 1999 | K992956 | LUCITONE FRS FLEXIBEL DENTAL RESIN | EBI | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
Compare with other makers
- All makers of Clasp, Preformed
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Powder, Porcelain
- All makers of Alloy, Gold-Based Noble Metal
- All makers of Alloy, Metal, Base
- All makers of Denture, Plastic, Teeth
Updated October 31, 2007. 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.