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DEXIS Titanium Sensor Kit

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1.014.5207Model 1.012.6180

by Dental Imaging Technologies Corporation

Identity

Trade Name
DEXIS Titanium Kit EUDAMED
DEXIS Titanium Sensor Kit FDA UDI
Generic Name
Dental digital imaging sensor, intraoral FDA UDI
Device Name
DEXIS Titanium Intraoral X-Ray Sensor EUDAMED
Model / Reference
1.014.5207 EUDAMEDFDA UDI
1.012.6180 EUDAMED

Identifiers

Primary DI / UDI-DI
D090101452070 EUDAMEDFDA UDI
Basic UDI-DI
++D090Polaris5J EUDAMED
510(k) Number
K172918 FDA UDI
FDA Product Code
MUH FDA UDI
EMDN Code
Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
GMDN Term
Dental digital imaging sensor, intraoral FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
Market of Registration
Finland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

DEXIS Titanium Sensor Kit by Dental Imaging Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K172918 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dental Imaging Technologies Corporation

Sources (2)

  • FDA UDI 839396e0-de2b-414d-8443-9605ec62ceb0 33 fields · synced Oct 6, 2026
  • EUDAMED f88c355f-b3b2-4ffb-9afc-fcd34cd7b875 61 fields · synced Jul 17, 2026