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Simplant®

FDA UDI

Class II (US FDA UDI)

by Dentsply Implants NV

Identity

Trade Name
SIMPLANT® FDA UDI
Generic Name
Panoramic/tomographic dental x-ray system application software FDA UDI
Device Name
SIMPLANT Editor FDA UDI
Model / Reference
Version 2 FDA UDI
Description
SIMPLANT Editor FDA UDI

Identifiers

Catalog Number
54500394E2 FDA UDI
Primary DI / UDI-DI
07392532181252 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Panoramic/tomographic dental x-ray system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Panoramic/tomographic dental x-ray system application software

Simplant® by Dentsply Implants NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Panoramic/tomographic dental x-ray system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply Implants NV

Sources (1)

  • FDA UDI 59345e5e-fa23-46bc-addb-920d9f96f708 35 fields · synced Jun 8, 2026