Data / Medical devices / United States / Exacta Dental Products, Inc.
Exacta Dental Products, Inc.: FDA-registered device maker in Clinton Township, MI, United States, 2 510(k) clearances
Exacta Dental Products, Inc. is registered with the FDA (registration 1836392) in Clinton Township, MI, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 17, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1836392
- FEI number
- 3003136707
- Address
- 44780 Macomb Industrial DR., Clinton Township, MI, United States, 48036
- Owner or operator
- EXACTA DENTAL PRODUCTS, INC. (9043538)
- Roles
- Repackager or relabeler
- First device listed
- January 23, 2009
- Registered through
- 2026
- Brand names listed
- EXACTA Mixing Tips, EXACTA Temp Xtra, FRESH Bold Impression Material
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 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 |
|---|---|---|---|---|---|---|
| June 17, 2011 | K102917 | FIXTEMP C&B | EBG | Substantially Equivalent | Exacta Dental Direct, Inc. | accessdata.fda.gov |
| January 13, 2006 | K053427 | FRESH, DENTAL IMPRESSION MATERIAL | ELW | Substantially Equivalent | Exacta Dental Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Restorative And Impression Material
- All makers of Material, Impression
- All makers of Crown And Bridge, Temporary, Resin
Updated June 17, 2011. 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.