TÜV SÜD Product Service GmbH· Ridlerstr. 65 · 80339 Munich · Germany DentalMaster (Xiamen) Medical Technology Co., Ltd. Area B, 1st & 4th Floor, Building 4 No. 18, Shanbianhong East Road, Haicang District 361026 XIAMEN PEOPLE'S REPUBLIC OF CHINA TÜV SÜD Product Service GmbH Confirmation Letter CL 122855 0001 Rev. 00 Reference: To whom it may concern, Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 (in the following referenced as MDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. With this letter TÜV SÜD Product Service GmbH, designated under MDR and identified by the number 0123 on NANDO, confirms that we have received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the above stated manufacturer with the following SRN Number: SRN Number: CN-MF-000022723 The devices covered by the formal application and the written agreement mentioned above are identified in the Tables below. - Table 1 identifies the devices for which an MDR application has been received, written agreement concluded and for which TÜV SÜD Product Service GmbH is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive. Registered Office: Munich Trade Register Munich HRB 85 742 UniCredit Bank AG · BIC HYVEDEMMXXX IBAN DE13 7002 0270 0048 8522 11 VAT ID No. DE129484267 Information pursuant to § 2 [1] DL-InfoV (Germany) at tuvsud.com/imprint Supervisory Board: Holger Lindner (Chairman) Board of Management: Walter Reithmaier (CEO) Patrick van Welij TÜV SÜD Product Service GmbH Ridlerstr. 65 80339 Munich Germany

Table 2 identifies the devices for which an MDR application has been received and a written agreement concluded, but TÜV SÜD Product Service GmbH has not yet taken the responsibility for appropriate surveillance of the corresponding devices under the applicable Directive. If devices covered by certificates issued under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) that expired after 26 May 2021 and before 20 March 2023, without having been withdrawn, this letter also confirms that - the manufacturer signed the written agreement under MDR by the date of MDD/AIMDD certificate expiry;...

Table 1: Devices covered by this letter and for which TUV SUD Product Service GmbH is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive:

Table 2: Devices covered by this letter and for which TUV SUD Product Service GmbH is NOT responsible for appropriate surveillance of the corresponding devices under the applicable Directive:

Confirmation Letter Version History Date