PROROOT MTA WHITE, PROROOT MTA GRAY

K142178 · Dentsply International, Inc. · KIF · Feb 26, 2015 · Dental

Device Facts

• Record ID: K142178
• Device Name: PROROOT MTA WHITE, PROROOT MTA GRAY
• Applicant: Dentsply International, Inc.
• Product Code: KIF · Dental
• Decision Date: Feb 26, 2015
• 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 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

ProRoot MTA (White/Gray) is a powder composed of fine hydrophilic particles; sets in presence of moisture; hydration creates colloidal gel; solidifies into strong, impermeable barrier; cures over four weeks. Used by dental professionals in clinical settings for endodontic procedures and pediatric pulpotomy. Device acts as a physical barrier/filling material to seal root canals, perforations, or pulp chambers. Benefits include effective sealing of dental structures to support healing and tooth preservation.

Clinical Evidence

No new clinical testing performed. Evidence based on review of independently reviewed medical literature regarding use of ProRoot MTA for pulpotomy in pediatric patients. Literature review included 171 pediatric patients covering 408 primary teeth.

Technological Characteristics

Powder consisting of fine hydrophilic particles; sets via hydration in presence of moisture to form a colloidal gel; cures to an impermeable barrier over four weeks. No changes to materials or quality requirements compared to predicate devices.

Indications for Use

Indicated for root end filling, apical plug during apexification, repair of root perforations (endodontic 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

• White MTA Material (K011009)
• MTA Material II (K981620)

Submission Summary (Full Text)

{0}------------------------------------------------

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

February 26,2015

Dentsply International Inc. Helen Lewis Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17401

Re: K142178

Trade/Device Name: Pro Root MTA Regulation Number: 21 CFR 872.3820 Regulation Name: Regulatory Class: II Product Code: KIF Dated: November 24, 2014 Received: November 28, 2014

Dear Ms. Helen Lewis:

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, listing 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.

{1}------------------------------------------------

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/Resourcesfor You/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 yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name(s): ProRoot MTA White/Gray (Pediatric Pulpotomy)

### Indications for Use:

- A root end filling material ●
- For the repair of repair of root canals as an apical plug during apexification 0

14217

- 0 For repair of root perforations during root canal therapy or as a consequence of internal resorption
- As a pulp capping material 0
- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 0 years) pediatric patient populations

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

# SECTION 5. 510(k) SUMMARY for ProRoot MTA White/Gray (Pediatric Pulpotomy)

- 5.1 Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, PA 17401

| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |

Date Prepared: 04 August 2014

- 5.2 Device Name:

| Proprietary Name: | ProRoot MTA White<br>ProRoot MTA Gray |
|----------------------|---------------------------------------|
| Classification Name: | Resin, root canal filling |
| CFR Number: | 872.3850 |
| Device Class: | II |
| Product Code: | KIF |

- 5.3 Predicate Devices:

| Predicate Device<br>Name | 510(k) | S.E. Date | Company Name |
|--------------------------|---------|---------------|------------------------------|
| White MTA Material | K011009 | May 2, 2001 | DENTSPLY International, Inc. |
| MTA Material II | K981260 | July 31, 1998 | DENTSPLY International, Inc. |

- 5.4 Description of Device:
The proposed ProRoot MTA White/Gray (Pediatric Pulpotomy) is identical to the predicates White MTA Material, K011009 and MTA Material II, K981620.

ProRoot MTA White and ProRoot MTA 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 that fully cures over a four-week period.

{4}------------------------------------------------

### 5.5 Indications for Use:

- o A root end filling material
- For the repair of repair of root canals as an apical plug during apexification o
- For repair of root perforations during root canal therapy or as a consequence of o internal resorption
- o As a pulp capping material
- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-0 21 years) pediatric patient populations

### 5.6 Substantial Equivalence:

## Technological Characteristics.

| | Predicate Device | Predicate Device | Proposed Device |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | White MTA Material | MTA Material II | ProRoot MTA White/Gray |
| | K011009 | K981620 | (Pediatric Pulpotomy) |
| Indications<br>for Use | • Repair of root perforation during root canal therapy (endodontic therapy), or as a consequence of internal resorption;<br>• Repair of root canals as an apical plug during apexification;<br>• Root end filling material; and<br>• Pulp capping material | • A root end filling material. | • A root end filling material<br>• For the repair of 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 |

{5}------------------------------------------------

| Features | ProRoot MTA White and<br>ProRoot MTA Gray is a<br>powder consisting of fine<br>hydrophilic particles that set<br>in the presence of moisture.<br>Hydration of the powder<br>creates a colloidal gel that<br>solidifies to form a strong<br>impermeable barrier that<br>fully cures over a four-week<br>period. | ProRoot MTA<br>White and ProRoot<br>MTA Gray is a<br>powder consisting of<br>fine hydrophilic<br>particles that set in<br>the presence of<br>moisture. Hydration<br>of the powder<br>creates a colloidal<br>gel that solidifies to<br>form a strong<br>impermeable barrier<br>that fully cures over<br>a four-week period. | ProRoot MTA White and<br>ProRoot MTA Gray is a<br>powder consisting of fine<br>hydrophilic particles that set<br>in the presence of moisture.<br>Hydration of the powder<br>creates a colloidal gel that<br>solidifies to form a strong<br>impermeable barrier that<br>fully cures over a four-week<br>period. |
|----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

#### 5.7 Non-Clinical Performance Data:

The quality requirements for the devices have not changed as a result of this filing. Only the proposed Indications for Use for the ProRoot MTA White/Gray (Pediatric Pulpotomy) have been modified as compared to the predicates White MTA Material, K011009 and MTA Material II, K981620. The results of performance testing and biocompatibility testing conducted for the predicate devices, White MTA Material (K011009) and MTA Material II (K981620) are valid, therefore, no additional performance testing or biocompatibility testing has been performed.

#### 5.8 Clinical Performance Data:

ProRoot MTA White and ProRoot MTA Gray have been sold by DENTSPLY International and its predecessors since February 10, 1997 and have been in use as a dental repair material since that time. ProRoot MTA White/Gray (Pediatric Pulpotomy) have been studied extensively in technical literature by dental professionals', and based on the completed studies (pulpotomy in 171 pediatric patients covering 408 primary teeth), it is appropriate to add pulpotomy of primary teeth as an indication for use in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations for ProRoot MTA White and ProRoot MTA Gray.

Review of relevant clinical data available in independently reviewed medical literature and the consideration of clinical use is germane when assessing the safety and effectiveness of the device when adding a primary indication directed

¹ Srinivasan, V, et al "Mineral trioxide aggregate in paediatric dentistry" International Journal of Paediatric Dentistry, 19:34-47, 2009.

{6}------------------------------------------------

at the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations.

### Conclusion as to Substantial Equivalence

5.9

The ProRoot MTA White and ProRoot MTA Gray material covered by this application are substantially equivalent to the predicate devices, as they are identical to the predicate devices and the purpose of this application is only to define a new indication for use for a special population of patients [child (ages >2-12 years) and adolescent (ages >12-21 years)].2

2 Guidance for Industry and FDA Staff "Premarket Assessment of Pediatric Medical Devices" March 14, 2014

Traditional 510(k)

ProRoot MTA White/Gray (Pediatric Pulpotomy)

DENTSPLY International 4