← Back to catalogue

DEXcam4™ Intra-oral camera

FDA UDI

Class I (US FDA UDI)

by Dexis Llc

Identity

Trade Name
DEXcam4™ Intra-oral camera FDA UDI
Generic Name
Multi-purpose digital medical camera FDA UDI
Model / Reference
1.011.4984 FDA UDI

Identifiers

Catalog Number
PLU760 FDA UDI
Primary DI / UDI-DI
EKAV101149840 FDA UDI
510(k) Number
K040691 FDA UDI
FDA Product Code
EIA FDA UDI
GMDN Term
Multi-purpose digital medical camera FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Multi-purpose digital medical camera

DEXcam4™ Intra-oral camera by Dexis Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose digital medical camera.

Cleared under the same submission

K040691 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dexis Llc

Sources (1)

  • FDA UDI 008c8ecc-55ed-4692-9baf-559f744c37a3 36 fields · synced May 30, 2026