FDA.reportPublic FDA data

DEXcam3™ intraoral cameras

Primary DI
EKAV100713330
Brand
DEXcam3™ intraoral cameras
Company
DEXIS LLC
Model
1.007.1333
Catalog number
PLU790
Device description
Digital intraoral camera
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUNIT, OPERATIVE DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040691000INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100DWin-Us Technology Co., Ltd.2004-03-23EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100713330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical cameraA battery-powered hand-held digital electro-optical device designed to capture video or still image data for a variety of medical applications (e.g., ophthalmoscopic, otoscopic and dermatoscopic) using dedicated interchangeable lenses. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It typically has a user display screen for visualization before image capture, and a docking cradle for battery recharging and connection to a personal computer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18888833947support@dexis.com

Regulatory Flags#

DUNS number
019717844
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV100879340DEXIS 10 (DEXIS Imaging Suite)101.008.79342022-01-21
EKAV101244750DEXIS™ Software111.012.44752021-11-12
EKAV101289030DEXcam3™ intraoral cameras1.012.89031.012.89032021-11-12
EKAV101289070DEXcam3™ intraoral cameras1.012.89071.012.89072021-11-12
EKAV082250710DEXIS Platinum™ intraoral sensor0.822.5071PLU5101S2016-09-24
EKAV082250730DEXIS Platinum™ intraoral sensor0.822.5073PLU5102C2016-09-24
EKAV082251940DEXIS Platinum™ intraoral sensor0.822.5194PLU6902016-09-24
EKAV100719690DEXcam3™ intraoral cameras1.007.1969PLU7912016-09-24
EKAV100730420DEXIS Platinum™ intraoral sensor1.007.3042PLU5101I2016-09-24
EKAV100898740DEXIS Platinum™ intraoral sensor1.008.9874PLU690K2016-09-24
EKAV100898770DEXIS Platinum™ intraoral sensor1.008.9877PLU690R2016-09-24
EKAV101034080DEXIS™ Software9PLU2362017-04-14
EKAV101034090DEXIS™ Software9PLU2352017-04-14
EKAV101034110DEXIS™ Software9PLU3492017-04-14
EKAV101034120DEXIS™ Software9PLU2382017-04-14
EKAV101135330DEXIS™ Software11101244792016-12-19
EKAV101149840DEXcam4™ Intra-oral camera1.011.4984PLU7602016-09-24
EKAV101149960DEXcam4™ Intra-oral camera1.011.4996PLU7610K2016-09-24
EKAV101184170DEXIS Platinum™ intraoral sensor1.011.8417PLU5109S2016-09-24
EKAV101184180DEXIS Platinum™ intraoral sensor1.011.8418PLU5109C2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975220031162Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975220031179Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975659690060YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690077YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690107YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690114YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-07
00841709109805MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109812MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109843MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109850MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109874MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109881MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110030MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110054MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110061MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111846MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111853MidmarkMIDMARK CORPORATIONEIA2026-09-28
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-09-04
00850043433514E300 Dr./Asst Rear DeliveryEngle Dental Systems, LLCEIA2025-08-26
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyEngle Dental Systems, LLCEIA2024-11-06
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08