D-Guide

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

No FDA recalls on record, checked 24 Oct 2026.

Trade Name

Panthera D-Guide Double sided

Generic Name

Dental impression tray, reusable

Device Name

D-Guide

Model / Reference

60066 EUDAMED

1 GUDID

Primary DI / UDI-DI

07540204000305

Basic UDI-DI

7540204D-GUIDECD

FDA Product Code

EHY

EMDN Code

Q01020199 Dental impression materials - other

GMDN Term

Dental impression tray, reusable

Device Class

Class I

Regulation Number

872.6880

Market of Registration

France

GUDID distribution status

In Commercial Distribution

EUDAMED SRN

CA-MF-000017831

Authorised representative

Obelis s.a. BE-AR-000000106

• '0.046'' 30mm

  Class I

  CE/MDR GUDID on market

• Double

  Class I

  CE/MDR

• Panthera Occlusal Appliance

  Unclassified

  FDA 510(k) K203596 Active Cleared 20 Apr 2021

• Panthera Dental Milled Bars

  Class II

  FDA 510(k) K183580 Active Cleared 20 Jun 2019

• The Panthera Anti-Snoring X3 Device

  Class II

  FDA 510(k) K171576 Active Cleared 22 Feb 2018

• The Panthera Anti-Snoring Device

  Class II

  FDA 510(k) K143244 Active Cleared 15 Dec 2014

See all devices from Panthera Dental, Inc. →