Data / Medical devices / United States / Endo Direct, LLC
Endo Direct, LLC: FDA-registered device maker in Monroe, NJ, United States, 4 510(k) clearances
Endo Direct, LLC is registered with the FDA (registration 3027344570) in Monroe, NJ, United States. It lists 10 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 28, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3027344570
- Address
- 24 Abeel Rd, Monroe, NJ, United States, 08831
- Owner or operator
- Endo Direct, LLC (10088054)
- Roles
- Repackager or relabeler
- First device listed
- May 18, 2023
- Registered through
- 2027
- Brand names listed
- EndoCeramic Root Repair Material
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleanser, Root Canal | KJJ | U | Repackager or relabeler | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Reamer, Pulp Canal, Endodontic | EKP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 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 |
|---|---|---|---|---|---|---|
| August 28, 2024 | K241457 | Vista BC Putty | KIF | Substantially Equivalent | Inter-Med, Inc. | accessdata.fda.gov |
| November 21, 2022 | K221811 | Vista BC Sealer | KIF | Substantially Equivalent | Inter-Med, Inc. | accessdata.fda.gov |
| September 9, 2020 | K193409 | Vista Rinse, Vista Rinse Plus | KJJ | Substantially Equivalent | Inter-Med/Vista Dental Products | accessdata.fda.gov |
| April 3, 2009 | K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | KJJ | Substantially Equivalent | Inter-Med, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleanser, Root Canal
- All makers of Colorimeter, Photometer, Spectrophotometer For Clinical Use
- All makers of Point, Paper, Endodontic
- All makers of Post, Root Canal
- All makers of File, Pulp Canal, Endodontic
- All makers of Reamer, Pulp Canal, Endodontic
Updated August 28, 2024. 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.