FDA.reportPublic FDA data

DEXcam4 HD

Primary DI
D090101289030
Brand
DEXcam4 HD
Company
Dental Imaging Technologies Corporation
Model
1.012.8907
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
D090101289030PackageHIBCC1In Commercial Distribution
D090101289070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical cameraAn electrically-powered, hand-held digital electro-optical device designed to capture video or still image data for multiple medical applications (e.g., ophthalmoscopic, otoscopic, and dermatoscopic) using dedicated interchangeable lenses/attachments. 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 may include a user display screen for visualization before image capture, and sometimes a docking cradle for battery recharging and connection to a personal computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800111106
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00693856000340DEXIS Imprevo SLIM TIPDEXIS Imprevo59456602026-08-07
D090101399140DEXIS IXS Size 2 Accessory Layer1.013.99142026-08-03
D090101399150DEXIS IXS Size 2 Accessory Layer1.013.99152026-08-03
D090101399160DEXIS IXS Size 2 Accessory Layer1.013.99162026-08-03
D090101399170DEXIS IXS Size 1 Accessory Layer1.013.99172026-08-03
D090101399180DEXIS IXS Size 1 Accessory Layer1.013.99182026-08-03
D090101399190DEXIS IXS Size 1 Accessory Layer1.013.99192026-08-03
D090101461070DEXIS IXS Size 1 Accessory Layer1.014.61072026-08-03
D090101461090DEXIS IXS Size 2 Accessory Layer1.013.29162026-08-03
D090101461480DEXIS Titanium Accessory Layer1.014.61482026-08-03
D090101461490DEXIS Titanium Accessory Layer1.014.61492026-08-03
D090101461500DEXIS Titanium Accessory Layer1.014.61502026-08-03
D090101461510DEXIS Titanium Accessory Layer1.014.61512026-08-03
D090101461520DEXIS Titanium Accessory Layer1.014.61522026-08-03
D090101397120IXS S2 Kit, CT, US, FR-CA1.013.97122026-05-12
00693856000203Assembly-IS 3700 SIDE TIPIS 3700TA08502025-12-04
00693856000227Assembly-IS 3700 POSTERIOR TIPIS 3700TA08602025-12-04
D090101329460DEXIS IXS Size 1 Sensor - R1.013.29461.013.29462026-04-01
D090101329470DEXIS IXS Size 2 Sensor - R1.013.29471.013.29472026-04-01
D090800045720DEXIS Ti2 Sensor - R - S8.000.45728.000.45722026-04-01

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