denterpriseintl.comQuickRayPRO
Denterprise International, Inc.
Denterprise International, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1000113729 | 1000113729 | Denterprise International, Inc. | 1 | Y | 2026-01-01 | 220 John Anderson Dr Ormond Beach FL US 32176 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00858475006016 | QuickRay HD #2 - Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure. | 800-323-2690 | info@denterpriseintl.com |
| 00858475006023 | QuickRay HD #1 - Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure. | 1-877-509-3180 | info@denterpriseintl.com |
| 00858475006184 | InstaRay - Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure. | 1-877-509-3180 | info@denterpriseintl.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 124106 | 1346694937 | K180561 | MobileX Portable X-ray System | EHD | 2018-04-04 |
| 124106 | 1544740735 | K160386 | ReadeR, VieweR, QuickScan PSP | MUH | 2016-03-10 |
| 124106 | 1340630074 | K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | MUH | 2015-11-10 |
| 124106 | 1009195543 | K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | EHD | 2015-12-03 |
| 124106 | 1281290557 | K151926 | QuickRay HD Intraoral Sensor | MUH | 2015-12-14 |
| 124106 | 2025653723 | K143703 | NICAL SMART MICRO CR system for intraoral dental images | MUH | 2015-03-18 |
| 124106 | 1440514825 | K133271 | OPTEO, VIDEOGRAPH HD | MUH | 2014-04-28 |
| 124106 | 1678024447 | K121132 | EZSENSOR P DIGITAL INTRAORAL SENSOR | MQB | 2012-05-10 |
| 124106 | 1277068804 | K113360 | MEDICAL IMAGE PROCESSING UNIT | EAP | 2012-02-07 |
| 124106 | 1864101666 | K102456 | INTRAORAL BELSENSOR GOLD | MUH | 2011-12-15 |
| 124106 | 1347576093 | K083532 | ADX4000-L, DX3000-L | MUH | 2009-03-10 |
| 124106 | 1731868181 | K070811 | CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 | MUH | 2007-07-05 |
| 124106 | 1886148647 | K070535 | RETROPAN CCD-TWAIN-USB | MUH | 2007-04-24 |
| 124106 | 1028374510 | K062237 | CADI, VERSION 4 | LLZ | 2006-11-20 |
| 124106 | 1885366147 | K020957 | ORACAM | EIA | 2002-06-13 |
| 124106 | 1284765901 | K001541 | MINICAM | EIA | 2000-07-21 |
| 124106 | 1415693260 | ||||
| 124106 | 1439531798 | ||||
| 124106 | 1462603433 | ||||
| 124106 | 1601388857 | ||||
| 124106 | 1707075159 | ||||
| 124106 | 1968652897 | ||||
| 124106 | 2061960891 | ||||
| 124106 | 1273607217 |
Product Codes Associated With Registrations#
PMN#
MobileX Portable X-ray System
Denterprise International, Inc.
QuickRay HD Intraoral Sensor
DENTERPRISE INTERNATIONAL, INC.
DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)
DENTERPRISE INTERNATIONAL, INC.
GUDID#
Smil-O-Ray - Portable X-ray System
2024-01-05
QuickRay DX Size 1 - 1
2023-07-25
QuickRay DX Size 2 - 2
2023-07-25
iCam - Intraoral Camera
2022-02-03
InstaRay - Size 1
2019-07-24
InstaRay - Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
2019-07-24
QuickRay HD #2 - Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.
2017-02-01
QuickRay HD #1 - Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
2017-02-01
Uni-Ray HD - Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
2017-02-17
Quick Ray HD No Logo #1 - Indications For Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
2017-02-01
QUICK Ray HD No Logo #2 - Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
2017-02-01
Xray2Go - Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
2017-02-01
QuickRay #1 - Intended for dental radiographic examination and diagnosis of disease of the teeth, jaw, and oral structure.
2017-02-01
QuickRay #2 - Intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.
2017-01-31
Xray2Go Mini - The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intra-oral image receptors. Its use is intended for both adults and pediatric subjects.
2017-02-01
MOBILE-X - The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental X-ray source for producing diagnostic X-ray images using intra-oral image receptors Its use is in adults and pediatric subjects.
2018-05-29
EZ-Flow - The EZ-Flow Anesthetic Delivery System is a device used for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with,dental procedures.
2018-03-19
Acuflow - The Acuflow Anesthetic Delivery System is a device used for injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedure.
2018-03-19