CMS Dental Size Verifier for Endodontic Obturators Instruction Manual

CMS Dental Size Verifier for Endodontic Obturators

Specifications

• Device Name: Size Verifier for Endodontic Obturators
• Intended Use: Endodontic Obturator System
• Single-Patient Use: Yes
• Device Classification: Class I
• Materials: Medical-grade materials

FAQs

• Q: Can the Size Verifier be reused on multiple patients?
  • A: No, the Size Verifier is designed for single-patient use only to prevent cross-contamination.
• Q: How should I dispose of the Size Verifier after use?
  • A: Follow local regulations for medical waste disposal to discard the Size Verifier properly.

The Obturator System

The system consists of the Soft-Core® Endodontic Obturator, the Size Verifier, and the Heater. These instructions for use contain information on how to handle and use the Size Verifier.

• Read the instructions for use carefully before using the device. Instructions for use are also available on the company web shop after login, https://www.cmsdentalshop.dk.
• Save the instructions for use for later use.
• For information on how to use the Endodontic Obturator and the Heater see the product’s instructions for use.
  • TD 208-25 IFU Soft-Core
  • TD 212-25 IFU Heater

Reporting serious incidents

• Any serious incident that may occur because of the use of the device must be reported to the manufacturer and the relevant authority in the country where the incident occurs.
• In Denmark, the competent authority is the Danish Medicines Agency.
• For further questions about the device please contact the manufacturer:

Size Verifier

The Size Verifier is an accessory to the obturator product. It is a helpful tool for the dentist but not a necessary tool to complete the root canal filling satisfactorily. It is NOT a measuring device.

Intended purpose

• The Size Verifier is intended to verify that there is enough space in the prepared root canal for the obturator to fit in, both in the axial and the vertical directions. The Size Verifier needs to have a loose fit and no resistance.

Device description and specification

• The Size Verifier consists of a plastic body with a handle molded in one piece and a length indicator (endo stop) placed on the body. The size is embedded in in device handle.
• The Size Verifier has the same dimensions as the corresponding obturator. A size 020 Size Verifier is corresponding to a size 020 obturator.

Sizes

• The Size Verifier is available in several sizes with differentiated tip diameters. Tip diameters vary from 0.20mm to 0.60mm.
• The Size Verifier has a taper of 3% over the first 13mm from the tip.

Single-patient use

• The Size Verifier is intended for single-patient use due to the risk of cross-contamination between patients.
• In the same treatment of a single patient the Size Verifier can be used multiple times as long as a state-of-the-art hygienic procedure is followed.

Intended users

• The Size Verifier is for professional use only.
• The Size Verifier is to be used only in a dental clinic or hospital environment by qualified dental professionals such as general practitioners as well as endo specialists and dental assistants.

Intended patient population

• The medical condition treated is endodontic treatment.
• Patients are people of all ages needing dental treatment within endodontic procedures.

Contra-indications

• There are no known contra-indications.

Limitations

• The Size Verifier is for professional use only. The Size Verifier must only be used in a dental clinic or hospital by qualified dental professionals such as general practitioners, endodontists, and dental assistants.
• The Size Verifier should only be used in connection with root canal procedures in teeth.

Side-effects / residual risks

• There are no known side effects.
• Take precaution upon usage of the Size Verifier to avoid penetration at the apical end, see section Step-by-step guide, 3.1.1 Preparation.

Clinical benefits to be expected

• Using the Size Verifier offers the possibility of defining the correct obturator dimension/size. Using the Size Verifier makes the dentist’s work easier and reduces discomfort for the patient by eliminating the need for further work on the
• root canal.

Precautions

• The Size Verifier should only be used as an accessory device when performing root canal procedures in teeth.

Liability

• The manufacturer disclaims all responsibility and liability for injury or damage to persons or property caused by faulty and/or inappropriate use.

Warnings

• Contamination risk
  • To avoid the risk of cross-contamination always follow the state-of-the-art rinse protocol after the user of the Size Verifier before insertion of the obturator.
• Single Patient Use
  • The Size Verifier is a device for single-patient use – Do not reuse it.
  • The material and design have not been tested and approved for long-term usage. The device could be damaged if used for numerous patients.
  • Do not use the device if the packaging has been damaged, unintentionally opened, or exposed to environmental conditions outside the limits specified on the enclosure.
  • The device could be compromised and damaged as well.
  • Do not use after the expiry date.
  • The material composition could change or be less flexible. Not suitable for insertion into the root canal.

Step-by-step guide

Preparation

• To ensure a proper root canal filling and to prevent contamination follow the state-of-the -art procedure for root canal fillings. Including the use of a rubber dam system during the endodontic procedure.
• Before using the Size Verifier, ensure that you have achieved the following:
• A coronally flared canal ensuring obturator has sufficient space to enter the root canal by using an orifice shaping instrument as necessary.
• An established working length.

Determine the working length

• Determine the working length by use of an electronic apex locator. It is recommended to measure the working length from the edge of the cusp to the apex.
• Mark the working length on the Size Verifier by adjusting the endo stop on the Size Verifier body, to the working length measured.

Choose the proper obturator size

• Use the Size Verifier to determine the correct obturator size for the root canal treatment.
• The Size Verifier does not stay in the root canal but is removed before the endodontic obturator is placed.
• Start by testing a Size Verifier in the prepared root canal that corresponds in size to the last file/instrument used.
• Place the Size Verifier manually in the root canal while keeping a grip on the handle with locking tweezers, or fingertips to secure holding it in place.
• The Size Verifier must easily slide into the root canal to the working length without force and resistance, it must go all the way to the apex.
• If the Size Verifier does not reach the working length, increase the taper of the of the root canal preparation, or use a smaller Size Verifier.
• The correct Size Verifier is the size which fits loosely all the way to the working length.
• Choose the obturator that corresponds to the fitting Size Verifier and discard the Size Verifier.
• After use of the Size Verifier continue to follow the state-of-the-art procedure for root canal fillings.

Technical Description

Device classification and conformity route

2017/745 (MDR), annex VIII.

Standard compliance

ISO 6877 Dentistry – Endodontic obturating materials

ISO 10993-1 Biological evaluation of medical devices

Declaration of shelf life

Environmental Conditions

temperature

Disposal

• The used Size Verifier could be contaminated.
• The used product must be handled as required by national law for dental clinics and disposed of as required.

Radiopacity

• The Size Verifier contains the material Tungsten which makes it possible to take a contrast X-ray of the root canal with the Size Verifier inserted.

Dimensions, taper, and size

• The Size Verifier is dimensioned to correspond to the same size endodontic obturator. A size 020 Size Verifier is corresponding to a size 020 Obturator.
• The mechanical dimensions comply with the definitions in ISO 6877.
• The obturator has a uniform taper of 3% over the first 13mm from the tip, therefore this is also the case for the size verifier.
• The obturator size 020 has a tip diameter of 0,20mm, therefore the tip diameter of the size verifier, size 020, is also 0,20mm.
• The size verifier has an overall length of 36mm.

Device dimensions for size and taper designation follow the standard, ISO 6877, and have the dimensions shown in the table.

Materials
The Size Verifier consists of a plastic body with a handle molded in one piece and a length indicator (Endo stop) placed on the body.

Parts

• Body/Handle– A flexible plastic body
  • The tapered plastic carrier is sufficiently flexible to negotiate curved canals.
  • The plastic body is radiopaque.
• Endo stop
  • An endo stop is provided to mark the working distance measurement already defined by an apex locator.

Symbols used

References

• CMS Dental Shop - produkter, tandplejemidler og udstyr til tandlæger

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