Data / Medical devices / United States / Karl Schumacher Dental, LLC
Karl Schumacher Dental, LLC: FDA-registered device maker in Northbrook, IL, United States, 1 510(k) clearance
Karl Schumacher Dental, LLC is registered with the FDA (registration 2520279) in Northbrook, IL, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 6, 2012. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2520279
- FEI number
- 3011900316
- Address
- 2501 Sanders Rd, Northbrook, IL, United States, 60062
- Owner or operator
- Karl Schumacher (2520279)
- Roles
- Repackager or relabeler
- First device listed
- September 21, 2016
- Registered through
- 2027
- Brand names listed
- Forceps, Tooth Extractor, Karl Schumacher Aspirating Syringe, Rongeur, Scissors
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 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 |
|---|---|---|---|---|---|---|
| November 6, 2012 | K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | EJI | Substantially Equivalent | Hu-Friedy Mfg. Co., LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Tooth Extractor, Surgical
- All makers of Scissors, Surgical Tissue, Dental
- All makers of Rongeur
- All makers of Syringe, Cartridge
Updated November 6, 2012. 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.