Registered with FDA
Endo Direct, LLC
Monroe, NJ, United States. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Endo Direct, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | EndoCeramic Root Repair Material | 2023 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | — | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | — | 2023 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | — | 2023 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Lister | — | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | — | 2023 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Endo Direct, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Inter-Med, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Aug 2024 | K241457 | Vista BC Putty | Inter-Med, Inc. | KIF Root Canal Filling Resin |
| 21 Nov 2022 | K221811 | Vista BC Sealer | Inter-Med, Inc. | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ENDO DIRECT, LLCFDA reg. 3027344570 | Monroe, NJ, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088054). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.