Registered with FDA
Denterprise International, Inc
Ormond Beach, FL, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 8
- 510(k) clearances
- 42012–2023
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Denterprise International, Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Lister | Disposable Cover Sheaths for MD770, iCam, ProSys, EyeCam Intraoral CamerasEyeCamEyeCam Intraoral CameraiCamiCam Intraoral CameraMD770 Intraoral CameraProSys Intraoral CameraTeliCam | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Denterprise International, Inc as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Jun 2023 | K231202 | QuickRayPRO | MUH Digital Extraoral Source X-Ray System |
| 4 Apr 2018 | K180561 | MobileX Portable X-ray System | EHD Extraoral with Timer X-Ray Unit |
| 14 Dec 2015 | K151926 | QuickRay HD Intraoral Sensor | MUH Digital Extraoral Source X-Ray System |
| 7 Dec 2012 | K122582 | DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) | EHD Extraoral with Timer X-Ray Unit |
Some of these clearances are listed with FDA today by another company: Remedi Inc. (1), Ningbo Runyes Medical Instrument Co., Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Denterprise International, Inc.FDA reg. 1000113729 | Ormond Beach, FL, United States | Complaint file establishment, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034629). 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.