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ScanX Barrier Envelope, 100 Pcs, Size 0

FDA UDI

Class II (US FDA UDI)

by Dürr Dental Se

Identity

Trade Name
ScanX Barrier Envelope, 100 Pcs, Size 0 FDA UDI
Generic Name
Dental digital imaging phosphor plate intraoral cover FDA UDI
Device Name
Light protection covers for image plates (used with the ScanX image plate scanners). FDA UDI
Model / Reference
100 Pcs, Size 0 FDA UDI
Description
Light protection covers for image plates (used with the ScanX image plate scanners). FDA UDI

Identifiers

Catalog Number
73248-0 FDA UDI
Primary DI / UDI-DI
E247732480 FDA UDI
510(k) Number
K190949 FDA UDI
FDA Product Code
PEM FDA UDI
GMDN Term
Dental digital imaging phosphor plate intraoral cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental digital imaging phosphor plate intraoral cover

ScanX Barrier Envelope, 100 Pcs, Size 0 by Dürr Dental Se — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental digital imaging phosphor plate intraoral cover.

Cleared under the same submission

K190949 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dürr Dental Se

Sources (1)

  • FDA UDI 50b79668-569b-40bc-b8c7-3815e2c0e976 35 fields · synced Jun 8, 2026