(202 days)
Not Found
No
The summary describes a material used for dental procedures and does not mention any computational or analytical capabilities that would involve AI/ML.
Yes
The device is used for therapeutic dental procedures, such as repairing root canals, acting as an apical plug, repairing root perforations, pulp capping, and pulpotomy.
No
The device is a root end filling and repair material, not a diagnostic tool. Its function is to solidify and form a barrier, which is a therapeutic action, not assessment or diagnosis.
No
The device description clearly states it is a powder that sets in the presence of moisture, indicating a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device's Intended Use: The intended uses listed for this device are all related to direct treatment and repair within the human body (root canals, root perforations, pulp capping, pulpotomy). It is a material that is placed in vivo.
- Lack of Specimen Examination: The device description and intended uses do not involve the examination of any specimens derived from the human body.
Therefore, this device, ProRoot MTA White and ProRoot MTA Gray, is a dental material used for therapeutic and restorative purposes within the mouth, not an IVD.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canals, root, pulp, primary teeth
Indicated Patient Age Range
child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 at the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3820 Root canal filling resin.
(a)
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.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
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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)
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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
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
| 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.
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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 | |||
| for Use | • Repair of root perforation during root canal therapy (endodontic therapy), or as a consequence of internal resorption; | ||
| • Repair of root canals as an apical plug during apexification; | |||
| • Root end filling material; and | |||
| • Pulp capping material | • A root end filling material. | • 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 |
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| Features | 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. | 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. | 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. |
| ---------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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.
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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