Product Name: Microscope Paste Carriers

Basic UDI-DI(s) ：69705149109MPC9

EMDN Code：Q01010299 ROOT CANAL FILLING DEVICES – OTHER

Intended Use:

Microscope Paste Carriers are hand-held operated instruments used for manually placing PDTM MTA White endodontic repair material.

Intended users and Environment of Use

Microscope Paste Carriers are to be used only in a clinical or hospital environment, following good dental practice, by qualified dental professionals such as general practitioners as well as Endo specialists (Endodontist) and Dental Assistants

Safety Information：

<Warnings>

• Only skilled dentists are allowed to use.

• Do not use this product except for the dental service and treatment. Use it in accordance with the intended use.

• Before Use: The single-use plunger must be cleaned and disinfected before use. Sterilization of reused instruments is essential before use.

• After use: Clean inside the head within 15 minutes. If this is not done, it may be very difficult to clean.

• Strictly follow this Instruction for Use and the General Processing Instructions For Endodontic Products to minimize following risks to the device, the patient

and/or the user:

○ Breakage of instrument.

○ Cross-contamination.

○ Heat generation due to insufficient lubrication and irrigation.

○ Swallowing of working part of the instrument.

○ Toxic or allergic reactions caused by processing residues.

<Contraindications and prohibitions>

Pregnant or breastfeeding women should use this product under the guidance of a doctor, weighing the benefits against the risks and avoiding unnecessary procedures.

<Adverse Reactions>

Temporary post-operative discomfort could arise generally as a result of receiving a root canal treatment.

Direction for Use

Refer to the illustrated user guide above.

1. Place one or more silicone stops on the tip of the corresponding needle using the key

2. Insert a plastic plunger into the corresponding needle.

3. Press the piston of the Syringe so that the bayonet tip appears.

4. Fit the plunger bayonet counter system and release the syringe piston.

5. Screw the head into the syringe. If a NiTi Memory Shapeneedle is used, adjust the shape of the needle manually to any required curvature.

6. Prepare the repair material on a glass tab and transfer the required quantity of material into the filling well. Thrust the tip (of the needle) into the repair material several times so that it is filled (the syringe piston must be fully released so that the greatest possible volume is available).

7. Remove excess material by sliding one silicone stop outside the tip.

8. Press the syringe piston to expel the material to goal place. Fill the instrument again if necessary.

9. Press the syringe piston 3 times immediately to expel the excess material when complete the treatment.

10. If a NiTi Memory Shape needle is used, straight up the needle manually.

11. Press the syringe piston and take the plunger out of the bayonet system.

12. Clean the inside of the head with a stiff threader dental floss immediately. For more detail see step number 1 of the reprocessing protocol.

13. Remove and discard any used or remaining silicone stops.

14. Clean all other parts in 15 minutes in order to remove any residual material.

Manufacturer Information

• Manufacturer Name: Shenzhen Denco Medical Co., Ltd

• Manufacturer Address: Room 3108, Block 6, Tian'an Cloud Park, Bantian street, Longgang District, Shenzhen, 518129 Guangdong P.R. China

• Factory Address: Room 101, 201, 301B, 401, 701&801, Block 5, Renluo 6 Road No. 6, Shuikou Street, Huicheng District, Huizhou, 516000 Guangdong, P.R. China

• Single Registration Number (SRN) of Manufacturer: CN-MF-000014271

Notified Body Information

• Notified Body Name: TÜV Rheinland LGA Products GmbH

• Address: Tillystraße 2, 90431, Nürnberg, Germany

• Notified Body Number: 0197

Authorised representative (AR) Information

• Authorised representative Name: Share Info GmbH

• AR’s Address: Am Schulzentrum 12, 41564 Kaarst, Germany

• Single Registration Number (SRN) of AR: DE-AR-000005132

This device is supplied with paper instructions for use. Please carefully read the instructions before use.