Gutta Percha Points

Product Name: Gutta Percha Points

Basic UDI-DI(s) ：69705149113GPAY

EMDN Code：Q010102 ROOT CANAL FILLING DEVICES

Intended Use:

Gutta Percha Points are intended to fill the shaped, cleaned and irrigated root canal space.

Intended users and Environment of Use

 Gutta Percha Points 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>

1. Gutta Percha Points are a single-use products. Single-use products shall not be re-processed nor reused. Reusing these products increases the risk of cross-contamination and/or breakage.

Use of the devices might lead to the following residual risks:

• Dissatisfaction of the user and delay in treatment / Patient discomfort.

• Retreatment (initial infection never heated)

• Serious infection / Serious health consequences for the patient (infection, toxic or allergic reaction for the patient).

• Fracture of the tooth due to obturation instruments.

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

3. Cleaning and disinfection of the product must be done according to the instructions in the manual.

<Contraindications and prohibitions>

None.

<Adverse Reactions>

None. In the present technical state, no adverse reaction has been reported so far.

Direction for Use

The Gutta Percha Points shall only be used in a clinical or hospital environment, by qualified dental professionals. After shaping and cleaning the root canal, the obturation technique must be set by the professional.

This procedure includes the use of Gutta Percha Points and sealer.

1. Gutta Percha Points selected shall come from the same shaping system and correspond to color code and shaping file size of the last instrument used during canal preparation. The point shall fit the apical size of the last instrument used and a small friction should be felt when withdraw (tug-back).

2. The points are to be disinfected prior to use.

3. A heated instrument can be used to soften and cut the material and ensure perfect sealing and dimensional adaptation of the root canal.

4. In the use of a heated instrument, follow the IFU of said instrument.

5. Use an appropriate tool to cut the Gutta Percha Points, including color coding ring, if present, after the insertion of the Gutta Percha Points in the root canal. The colored ring shall not remain in the root canal after insertion.

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.