Data / Medical devices / United States / Healthdent'l, LLC
Healthdent'l, LLC: FDA-registered device maker in Plainfield, IL, United States, 2 510(k) clearances
Healthdent'l, LLC is registered with the FDA (registration 3013411964) in Plainfield, IL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 27, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013411964
- Address
- 10052 Bode ST Ste E, Plainfield, IL, United States, 60585
- Owner or operator
- HealthDentl LLC (10053526)
- Roles
- Manufacturer
- First device listed
- December 14, 2016
- Registered through
- 2026
- Brand names listed
- Hema Benz, Hema Glu
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 27, 1995 | K953405 | HEMA-BENZ | KLE | Substantially Equivalent | Health-Dent Intl., Inc. | accessdata.fda.gov |
| May 12, 1995 | K951220 | HEMA-GLU | KLE | Substantially Equivalent | Health-Dent Intl., Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 27, 1995. 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.