Royal Shield Powder Free Latex Dental Dam

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

Device Name

Royal Shield Powder Free Dental Dam

Model / Reference

L-DD-55-BG-T-BL

Primary DI / UDI-DI

09551008830003

Basic UDI-DI

955100883RSDDJ7

Direct Marketing DI

09551008830003

EMDN Code

Q019002 Dentistry dams and hooks, single-use

Device Class

Class I

EU market of registration

Poland

EUDAMED SRN

MY-MF-000024531

Authorised representative

Wellkang Ltd XI-AR-000001836

• Royal Shield Rubber Dams

  Class I

  FDA 510(k) K942992 Active Cleared 21 Sep 1994

• Standard Rubber Dam with or Without Frames

  Class I

  FDA 510(k) K905470 Active Cleared 25 Apr 1991

• Royal Shield Non-Sterile Powder-Free Rubber Dams

  Class I

  FDA 510(k) K952628 Active Cleared 19 Oct 1995