Unit, X-ray, Intraoral

Product Code: EAP

Dental Dental Diagnostic X-Ray Equipment

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31]

Code of Federal Regulations: 872.1810


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as EAP

5255Unit, X-ray, IntraoralIntraoral Source X-ray System.

Total Product Life Cycle (TPLC) Devices

5255Unit, X-ray, IntraoralIntraoral Source X-ray System.

FDA Consensus Standards

Unit, X-Ray, Intraoral [37034]21 CFR §872.1810 🔎
Unit, X-Ray, Intraoral [29008]21 CFR §872.1810 🔎

Pre-market Notifications for EAP

K113360MEDICAL IMAGE PROCESSING UNITHUMANRAY CO,LTD
K102573PROVU (TM) DENTAL X-RAY SYSTEMADVANCED IMAGE SCIENCE, INC.
K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSCHICK TECHNOLOGIES, INC.
K080738DENTRON SENSORDENTRON SYSTEMS LLC
K052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)FLOW X-RAY CORP.
K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSCHICK TECHNOLOGIES, INC.
K960819HELIODENT DSPELTON & CRANE CO.
K960028ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEMDENTSPLY INTL.
K954565EXPLOR-X (AZTEH) HFCHICAGO X-RAY SYSTEMS, INC.
K953936ATLANTISTROPHY RADIOLOGIE
K950667AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMERCHICAGO X-RAY SYSTEMS, INC.
K950532TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYTROPHY RADIOLOGIE
K950533TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHYTROPHY RADIOLOGIE
K950030HELIODENT MDPELTON & CRANE CO.
K936068ORTHOPHOS 3/ ORTHOPHOS 3CPELTON & CRANE CO.

Global Unique Device Identification Database

D764B24310401Unit, X-Ray, Intraoral
D764B24041001Unit, X-Ray, Intraoral
D764B12180011Unit, X-Ray, Intraoral
D764B12090521Unit, X-Ray, Intraoral
D764B11180021Unit, X-Ray, Intraoral
D764B11120501Unit, X-Ray, Intraoral
D764B1104050R1Unit, X-Ray, Intraoral
D764B10730921Unit, X-Ray, Intraoral
D764B10720061Unit, X-Ray, Intraoral
D764B10720031Unit, X-Ray, Intraoral
D764B10711021Unit, X-Ray, Intraoral
D76464835851Unit, X-Ray, Intraoral
D76461736241Unit, X-Ray, Intraoral
60889978024391UNIT, X-RAY, INTRAORAL
60889978024384UNIT, X-RAY, INTRAORAL

Maude Adverse Events

VETPRO DCMIDMARK CORPORATION2019-06-28
2019-06-06
PREVAMIDMARK CORPORATION2019-01-29
VETPROMIDMARK CORPORATION2018-10-30
X-RAY MACHINEUNK2018-08-07
JB-70MIDMARK CORPORATION2018-05-11
PREVAMIDMARK CORPORATION2018-04-12
PREVAMIDMARK CORPORATION2018-03-06
IRIX 70TROPHY RADIOLIGIE2009-06-12
TROPHIE RADIOLOGIE MODEL AD 332TROPHIE RADIOLOGIE, SA2009-01-22
IRIX 70TROPHY RADIOLIGIE2008-12-22
ORTHORALIX SD II PANORAMIC X-RAY SYSTEMGENDEX DENTAL SYSTEMS2008-10-17
GX770 INTRAORAL X-RAY SYSTEMGENDEX DENTAL SYSTEMS2008-10-15
765DC INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-10-09
765DC INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-10-09
IRIX 70TROPHY RADIOLOGIE2008-10-08
IRIX 70TROPHY RADIOLIGIE2008-08-28
765DC INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-07-29
GX770 INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-07-10
765DC INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-07-10
EXPERT DC INTRAORAL X-RAYGENDEX DENTAL SYSTEM2008-07-02
GX770 INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-06-04
GX770 INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-06-04
IRIX 70TROPHY RADIOLIGIE2008-05-01
GX770 INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-04-04
GX770 INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-04-03
GX765DC INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-04-03
GX765DC INTRAORAL X-RAYGENDEX DENTAL SYSTEMS2008-02-15
IRIX 70TROPHY RADIOLIGIE2007-07-19
770 INTRAORAL X-RAY SYSTEMGENDEX IMAGING2007-04-12
765DC INTRAORAL X-RAY SYSTEMGENDEX IMAGING2007-04-12
IRIX 70TROPHY RADIOLIGIE2007-03-06
IRIX 70TROPHY RADIOLIGIE2007-03-06
IRIX 70TROPHY RADIOLIGIE2007-03-06
IRIX 70TROPHY RADIOLOGIE2006-09-30
IRIX 70TROPHY RADIOLIGIE2006-08-31
IRIX 70TROPHY RADIOLIGIE2006-08-31
IRIX 70TROPHY RADIOLIGIE2006-05-15
IRIX 70TROPHY RADIOLIGIE2006-05-15
IRIX 70TROPHY RADIOLIGIE2006-05-15
IRIX 70TROPHY RADIOLIGIE2006-05-15
IRIX 70TROPHY RADIOLOGIE2006-02-10
IRIX 70TROPHY RADIOLOGIE2006-02-10
IRIX-70TROPHY RADIOLOGIE2005-11-02
SUGMA SENSORGE HEALTHCARE FINLAND OY2005-05-19
IRIX-70TROPHY RADIOLOGIE2004-11-18
IRIX-70TROPHY RADIOLOGIE2004-11-18
IRIX-70TROPHY RADIOLOGIE2004-11-18
IRIX-70TROPHY RADIOLOGIE2004-11-03
IRIX-70TROPHY RADIOLOGIE2004-11-03
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