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
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
D090800045730DEXIS IXS Size 1 Sensor - S8.000.45738.000.45732026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - S8.000.45748.000.45742026-04-01
D090800045750DEXIS IXS Size 2 Sensor - S8.000.45758.000.45752026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - S8.000.45768.000.45762026-04-01
D090800045770DEXIS Ti2 Kit - S8.000.45778.000.45772026-04-01
D090800045780DEXIS IXS Size 2 Sensor - D8.000.49788.000.49782026-04-01
D090800045790DEXIS IXS S1 Kit8.000.45798.000.45792026-04-01
D090800045810DEXIS IXS S2 Kit8.000.45818.000.45812026-04-01
D090800045830DEXIS Ti2 Kit - S8.000.45838.000.45832026-04-01
D090800045840DEXIS Ti2 Kit - R - S8.000.45848.000.45842026-04-01
D090800045850IXS S1 Warranty Replacement - S8.000.45858.000.45852026-04-01
D090800045860IXS S1 Warranty Replacement Kit8.000.45868.000.45862026-04-01
D090800045870IXS S2 Warranty NEW Kit8.000.45878.000.45872026-04-01
D090800045880IXS S2 Warranty Replacement Kit8.000.45888.000.45882026-04-01

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Primary DI, Brand, Company table
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