SavDenTM MTA Root Canal Filling Materials

K162661 · Tyds Biotech Incorporation · KIF · Apr 25, 2017 · Dental

Device Facts

• Record ID: K162661
• Device Name: SavDenTM MTA Root Canal Filling Materials
• Applicant: Tyds Biotech Incorporation
• Product Code: KIF · Dental
• Decision Date: Apr 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

A root end filling material. For the repair of root canals as an apical plug during apexification. For repair of root perforations during root canal therapy or as a consequence of internal resorption. As a pulp capping material. Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations.

Device Story

SavDen™ MTA is a root canal filling material consisting of fine, hydrophilic powder particles (calcium silicate and bismuth oxide) that set upon hydration. When mixed with water, the powder forms a colloidal gel that solidifies into an impermeable barrier (calcium silicate hydrate) to seal root canals, perforations, or pulp exposures. Used by dental professionals in clinical settings. The material provides a physical barrier to support healing in endodontic procedures. Benefits include sealing capabilities for root repair and pulpotomy in pediatric patients.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Evidence is based on non-clinical bench testing, including biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, mutagenicity, muscle implant study) and performance testing (setting time, solubility, radio-opacity, pH, and XRD analysis).

Technological Characteristics

Powder-liquid system; powder contains calcium silicate and bismuth (III) oxide; liquid is sterilized water. Sets via hydration to form calcium silicate hydrate (C-S-H) colloidal gel. Radio-opacity > 3 mmAl; pH 12.4 ± 0.5; solubility < 3% by mass. Shelf life 2 years.

Indications for Use

Indicated for root end filling, apical plug during apexification, repair of root perforations (root canal therapy or internal resorption), pulp capping, and pulpotomy of primary teeth in pediatric patients (ages 2-21 years).

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Predicate Devices

• ProRoot MTA White/Gray (Pediatric Pulpotomy) (K142178)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

tYDS Biotech Incorporation Liang-Yu Chang Project Manager Rm. 7, 2F., No. 229, Fuxing 2nd Rd. Zhubei City, Hsinchu County 302 TAIWAN (R.O.C.)

Re: K162661

Trade/Device Name: SavDen™ MTA Root Canal Filling Materials Regulation Number: 21 CFR 872.3820 Regulation Name: Root canal filling resin Regulatory Class: Class II Product Code: KIF Dated: February 24, 2017 Received: February 27, 2017

Dear Liang-Yu Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

April 25, 2017

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Change Control Table, Change History

# Change Control Table

| Version | Document Author | Document Approver | Date Approved |
|---------|---------------------|---------------------|---------------|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |

Complete Change Control Table (all versions) retained in SWIFT Docs.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

SavDenTM MTA Root Canal Filling Materials

Indications for Use (Describe)

- A root end filling material.

- For the repair of root canals as an apical plug during apexification.

- For repair of root perforations during root canal therapy or as a consequence of internal resorption.

- As a pulp capping material.

- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k), K162661/S002 510 (k) Summary

# 510(k) Summary

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Traditional 510(k), K162661/S002 510 (k) Summary

## 510(k) SUMMARY

| 5.1 | <b>Type of Submission:</b> | Traditional |
|-----|----------------------------|----------------|
| 5.2 | <b>Date of Summary:</b> | April 25, 2017 |

| 5.3 | Submitter: | tYDS Biotech Incorporation |
|----------|------------|----------------------------------------------------------------------------------------|
| Address: | | Rm. 7, 2F, No.229, Fuxing 2nd Rd., Zhubei<br>City, Hsinchu County 302, Taiwan (R.O.C.) |
| | Phone: | [phone] |
| | Fax: | [phone] |
| Contact: | | Liang-Yu Chang ([e-mail]) |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | SavDen™ MTA Root Canal Filling<br>Materials |
|-------------------------|---------------------------------------------|
| Regulation Description: | Root canal filling resin. |
| Review Panel: | Dental |
| Regulation Number: | 872.3820 |
| Device Class: | II |
| Product Code: | KIF |

#### 5.4 Identification of the Predicate Device:

| Predicate Device Name: | ProRoot MTA White/Gray (Pediatric<br>Pulpotomy) |
|------------------------|-------------------------------------------------|
| Manufacturer: | Dentsply International Inc. |
| Regulation number: | 872.3820 |
| Device Class: | II |
| Product Code: | KIF |
| 510(k) Number: | K142178 |

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#### 5.5 Intended Use/ Indications for Use of the Device

- A root end filling material. -
- For the repair of root canals as an apical plug during apexification. -
- For repair of root perforations during root canal therapy or as a consequence of internal resorption.
- -As a pulp capping material.
- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent -(ages >12-21 years) pediatric patient populations.

## 5.6 Device Description

SavDen™ MTA powder consists of fine, hydrophilic particles that set in the presence of water. Hydration of the powder creates a colloidal gel that is solidified to form an impermeable barrier that fully cures over a four-week period.

# 5.7 Non-clinical Testing

A series of safety and performance tests were conducted on the proposed device, SavDen™ MTA Root Canal Filling Materials.

- Shelf life test
- . Biocompatibility test
- In Vitro Cytotoxicity Test MTT Assay
- Skin Sensitization Study (Maximization Test)
- White Rabbit Intracutaneous Irritation Test
- Acute Systemic Toxicity Study

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Traditional 510(k), K162661/S002 510 (k) Summary

- White Rabbit Pyrogen Test
- Salmonella Reverse Mutation Test
- In Vitro Mammalian Cell Gene Mutation Test
- In Vitro Mammalian Chromosomal Aberration Test
- Muscle Implant Study
- . Bench Test
- Setting time
- Solubility and disintegration
- Radio-opacity
- pH test
- X-ray diffraction testing
- . Animal Test

All the test results demonstrate that SavDen™ MTA Root Canal Filling Materials meets the requirements of its pre-defined acceptance criteria, and is substally equivalent to the predicate device.

### 5.8 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

### 5.9 Substantial Equivalence Determination

The SavDen™ MTA Root Canal Filling Materials has the same intended use, principle of operation and technological characteristics with the predicate device (K142178). A series of tests were performed and demonstrated substantial equivalence between the proposed and the predicate device. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.

| Item | Proposed device | Predicate device | | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Proprietary Name | SavDenTM MTA Root Canal<br>Filling Materials | ProRoot MTA White/Gray<br>(Pediatric Pulpotomy) | | |
| 510(k) No. | | K142178 | | |
| Intended Use | A root end filling material.<br>For the repair of root canals as an apical plug during apexification.<br>For repair of root perforations during root canal therapy or as a consequence of internal resorption.<br>As a pulp capping material.<br>Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations. | A root end filling material.<br>For the repair of root canals as an apical plug during apexification.<br>For repair of root perforations during root canal therapy or as a consequence of internal resorption.<br>As a pulp capping material.<br>Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations. | | |
| | Principle of Operation | SavDenTM MTA Root Canal Filling Materials is a powder consisting of fine, hydrophilic particles that set in the presence of water. Hydration of the powder creates a colloidal gel that solidifies (Calcium silicate hydrate, C-S-H) to form an impermeable barrier. | ProRoot MTA White/Gray is a powder consisting of fine hydrophilic particles that set in the presence of moisture. Hydration of the powder creates a colloidal gel that solidifies to form a strong impermeable barrier. | |
| | Component | Powder: Calcium silicate, Bismuth (III) oxide<br>Liquid: Sterilized water | Powder: Portland cement, Bismuth (III) oxide<br>Liquid: Pure water | |
| | | Materials Ratio<br>(wt %) | Calcium silicate 80%<br>Bismuth (III) oxide ( $Bi2O3$ ) 20% | Portland cement 80%<br>Bismuth (III) oxide ( $Bi2O3$ ) 20% |
| | | Setting Ratio | Liquid to powder ratio:<br>$[L]/[P] = 1/4$ | N/A * |
| | Solubility | | Not exceed 3% by mass | Not exceed 3% by mass |
| | Radio-opacity | > 3 mmAl | > 3 mmAl | |
| pH Value of<br>Extractable Matters | pH 12.4 ± 0.5 | pH 12.4 ± 0.5 | | |
| Product Shelf Life | 2 years | 2 years | | |

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Traditional 510(k), K162661/S002 510 (k) Summary

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* The predicate device does not disclose the setting ratio. In general, the setting ratio for the predicate device used by dentists is 0.3~0.4 g powder per 0.1 ml liquid.

### 5.10 Similarity and Differences

The difference between the proposed device and predicate device are component and setting ratio. We define a proposed ratio of 0.4 g powder per 0.1 ml liquid for the proposed device. But the predicate device does not disclose the setting ratio. In general, the setting ratio for the predicate device used by dentists is 0.3~0.4 g powder per 0.1 ml liquid.

We conducted the X-ray diffraction testing using X-Ray Diffraction to analysis the chemical composition of the proposed and predicate device. XRD analysis results revealed the substantial equivalence in the chemical composition of the proposed and predicate device.

The other properties of these two devices are the same. The proposed device has been conducted on safety and performance tests, and the results complied with the test requests. Therefore, the difference between the proposed and the predicate device did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate device in safety and performance claims.

### 5.11 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that SavDen™ MTA Root Canal Filling Materials is substantially equivalent to the predicate device.