(499 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical applications of a bioceramic cement, with no mention of AI or ML.
Yes
The device is described as an endodontic bioceramic reparative cement used for various dental treatments like treating perforations, pulp capping, and apexification, all of which aim to restore or repair damaged dental tissues.
No
Explanation: The device is an endodontic bioceramic reparative cement used for various dental treatments such as repairing perforations, pulp capping, and apexification. Its function is to treat and repair, not to diagnose.
No
The device description clearly states it is a "bioceramic reparative cement" composed of "mineral oxides in the form of fine hydrophilic particles." This describes a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed in vivo (within the body) to repair and treat issues within teeth and root canals. These are therapeutic and restorative actions.
- Device Description: The device is a bioceramic reparative cement designed to be placed directly into the anatomical site. It's a material used for physical repair and sealing.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Anatomical Site: The anatomical sites are parts of the tooth and surrounding structures, which are treated directly by the device.
- Performance Studies: The performance studies focus on the material's properties (setting time, radiopacity, solubility) and biological compatibility when implanted, which are relevant for a device used in vivo.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions;
- Via canal treatment of root perforation due to internal resorption;
- Surgical treatment of root perforation due to internal resorption;
- Periapical surgery with reverse filling;
- Pulp capping;
- Pulpotomy (removal of affected crown portion of the pulp preserving the vitality and function of the remaining radicular portion)
- Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp)
- Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
MTA REPAIR HP is an endodontic bioceramic reparative cement with high plasticity, composed of mineral oxides in the form of fine hydrophilic particles. It is indicated for cases of root perforation (canal and furcation), iatrogenic or by caries, root perforation by internal resorption, retrofilling, direct pulp capping, pulpotomy, apexigenesis, and apexification.
The plasticizer Polyvinylpyrrolidone is added in the subject device to improve the plasticity of the mixture powder/liquid, with plasticity being understood as the quality of being easily shaped or molded. Thus, the new formulation of the subject device improves handling and insertion into the dental cavity since the pasted after mixing becomes a molding putty type consistency.
The radiopacifier CaWO4 is also added in the subject device to prevent discoloration of the tooth, since CaWO4 does not reduce when exposed to sunlight, unlike Bi2O3 found in the predicate device. Overall properties noted for the subject device include the following:
- . Setting time: MTA Repair HP solidifies upon being maintained in a wet environment after spatulation. The start setting time is approximately 15 minutes.
- . Radiopacity: Similar to gutta-percha and more radiopaque than dentin and bone.
- . Absence of dental discoloring due to the radiopacifier CaWO4 used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal, furcation, root
Indicated Patient Age Range
Not Found
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)
Nonclinical Testing:
The subject device features technological characteristics previously cleared in other devices. MTA HP meets the applicable requirements of the following FDA recognized standards:
- ISO 10993-1 Biological evaluation of medical devices-part 1: evaluation and testing.
- ISO 10993.5: 2009 Biological evaluation for medical devices Tests for cytotoxicity: in vitro methods
- ISO 10993-6: 2007 Biological evaluation of medical devices part 6: Tests for local effects after implantation and protocol supplied by the vendor.
- ISO 10993-11: 2006 Biological evaluation of medical devices part 11: Tests for systemic toxicity, described in method TOX-052 Rev. 01.
- . ANSI/ADA Specification no. 57: Endodontic Sealing Material, 2000.
- . ISO 6876:2012 - Dentistry -- Root Canal Sealing Materials
Bench test results allowed us to conclude that MTA Repair HP is well suited for its intended use.
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.
(K112046) MTA-Angelus
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and merging into a single form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2016
Angelus Industria De Productos Odontologicos % Lilian Llull Regulatory Affairs Manager Techlink International PO Box 694125 Miami. Florida 33160
Re: K151047
Trade/Device Name: MTA Repair HP Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: July 5, 2016 Received: July 28, 2016
Dear Lilian Llull:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Michael J. Ryan -S
for 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
2
Indications for Use
510(k) Number (if known) K151047
Device Name MTA Repair HP
| Indications for Use (Describe) | * Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions;
- Via canal treatment of root perforation due to internal resorption;
- Surgical treatment of root perforation due to internal resorption;
- Periapical surgery with reverse filling;
- Pulp capping;
- Pulpotomy (removal of affected crown portion of the pulp preserving the vitality and function of the remaining radicular portion)
- Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp)
- Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
K151047
510(k) Summary
| Proprietary Name: | MTA Repair HP |
|---|---|
| Date of Submission: | August 29, 2016 |
| Submitter: | Angelus Industria de Productos Odontologicos |
| Waldir Landgraf, 101 | |
| Londrina, Brazil 86031-3200 | |
| TEL - +55 43 2101 3200 | |
| Official Contact: | Lilian Llull |
| TechLink International | |
| PO Box 694125 | |
| Miami, FL 33160 | |
| TEL - (305) 974 - 0088 | |
| Common Name: | |
| Trade Name: | |
| Classification: | |
| Product Code: | |
| Classification Panel: | |
| Regulation Numbers: | Root Canal Filling Resin |
| MTA REPAIR HP | |
| Class II | |
| KIF | |
| Dental | |
| 21 CFR 872.3820 | |
| Substantial Equivalence: | (K112046) MTA-Angelus |
Indications for Use:
- Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions
- Via canal treatment of root perforation due to internal resorption
- Surgical treatment of root perforation due to internal resorption
- Periapical surgery with reserve filling
- Pulp capping
- Pulpotomy (removal of affected crown portion of the pulp preserving the vitality and function of the remaining radicular portion)
-
- Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp)
-
- Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)
4
Device Description:
MTA REPAIR HP is an endodontic bioceramic reparative cement with high plasticity, composed of mineral oxides in the form of fine hydrophilic particles. It is indicated for cases of root perforation (canal and furcation), iatrogenic or by caries, root perforation by internal resorption, retrofilling, direct pulp capping, pulpotomy, apexigenesis, and apexification.
The plasticizer Polyviny|pyrrolidone is added in the subject device to improve the plasticity of the mixture powder/liquid, with plasticity being understood as the quality of being easily shaped or molded. Thus, the new formulation of the subject device improves handling and insertion into the dental cavity since the pasted after mixing becomes a molding putty type consistency.
The radiopacifier CaWO4 is also added in the subject device to prevent discoloration of the tooth, since CaWO4 does not reduce when exposed to sunlight, unlike Bi2O3 found in the predicate device. Overall properties noted for the subject device include the following:
- . Setting time: MTA Repair HP solidifies upon being maintained in a wet environment after spatulation. The start setting time is approximately 15 minutes.
- . Radiopacity: Similar to gutta-percha and more radiopaque than dentin and bone.
- . Absence of dental discoloring due to the radiopacifier CaWO4 used.
5
Device Comparison Table
| Element | Proposed Device
(K151047) | Predicate Device
(K112046) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | MTA REPAIR HP | MTA ANGELUS |
| Device Description | MTA REPAIR HP is an endodontic
bioceramic reparative cement with high
plasticity, composed of mineral oxides
in the form of fine hydrophilic particles.
It is indicated for cases of root
perforation (canal and furcation),
iatrogenic or by caries, root perforation
by internal resorption, retrofilling,
direct pulp capping, pulpotomy,
apexigenesis, and apexification. | MTA Angelus is mineral
trioxide aggregate cement
used for root repair during
endodontic treatment,
combining the powder and
liquid produces a colloidal gel
that solidifies to form a
barrier. |
| Common Name | Resin, Root Canal Filling | Resin, Root Canal Filling |
| Classification | Root Canal Filling Resin | Root Canal Filling Resin |
| Class | Class II | Class II |
| Product Code | KIF | KIF |
| Indications for
Use | * Treatment of perforations
of root canal and furcation
caused iatrogenically or
by caries lesions;
-
Via canal treatment of root
perforation due to internal
resorption; -
Surgical treatment of root
perforation due to internal
resorption; | * Treatment of perforations
of root canal and furcation
caused iatrogenically or by
caries lesions -
Via canal treatment of
root perforation due to
internal resorption -
Surgical treatment of
root perforation due to
internal resorption |
| | | |
| | * Periapical surgery with | * Periapical surgery |
| | reverse filling; | with reverse filling |
| | * Pulp capping; | * Pulp capping |
| | * Pulpotomy (removal of | * Pulpotomy (removal of |
| | affected crown portion of the | affected coronal pulp to |
| | pulp preserving the vitality and | preserve vitality of remaining |
| | function of the remaining | pulp tissue) |
| | radicular portion) | |
| | * Apexogenesis (induction of | * Apexogenesis |
| | root development in vital teeth | (indication of root |
| | with an inflamed coronal pulp) | development in vital teeth |
| | | with an inflamed coronal pulp) |
| | * Apexification (induction of | * Apexification (induction |
| | formation of a mineralized | of formation of a |
| | barrier at the root tip of young | mineralized barrier |
| | permanent teeth with | at the root tip of |
| | incomplete root | young permanent |
| | development | teeth with incomplete |
| | and a necrotic pulp) | root development |
| | | and a necrotic pulp) |
| | | |
| Biocompatibility | Biocompatible (Biological | Biocompatible |
| | Evaluation Report) | |
| Design | Powder (capsule) | Powder (bottle) |
| | Liquid (capsule) | Liquid (flask) |
| Shelf Life | 3 years | 3 years |
| | | |
| Standards | ISO 6876:2012 | ISO 6876:2012 |
| | ANS/ADA Nº 57 - 2000 | ISO 10993-1:2009 |
| | ISO 10993-1:2009 | |
| Composition:
powder | Tricalcium silicate
3CaO.SiO2 Dicalcium
silicate 2CaO.SiO2;
Tricalcium aluminate
3CaO. Al2O3;
Calcium Oxide CaO; Calcium
Tungstate CaWO4; | Tricalcium silicate
3CaO.SiO2; Dicalcium silicate
2CaO.SiO2; Tricalcium
aluminate
3CaO. Al2O3;
Calcium Oxide CaO; Bismuth
Oxide Bi2O3; |
| Composition:
liquid | Distilled water
Plasticizer
(Polyvinylpyrrolidone) | Distilled water |
| Packaging | 2 capsule system (powder and
liquid) | NA |
| Sterile | NA | NA |
6
7
Nonclinical Testing:
The subject device features technological characteristics previously cleared in other devices. MTA HP meets the applicable requirements of the following FDA recognized standards:
- ISO 10993-1 Biological evaluation of medical devices-part 1: evaluation and testing.
- ISO 10993.5: 2009 Biological evaluation for medical devices Tests for cytotoxicity: in vitro methods
- ISO 10993-6: 2007 Biological evaluation of medical devices part 6: Tests for local effects after implantation and protocol supplied by the vendor.
- ISO 10993-11: 2006 Biological evaluation of medical devices part 11: Tests for systemic toxicity, described in method TOX-052 Rev. 01.
- . ANSI/ADA Specification no. 57: Endodontic Sealing Material, 2000.
- . ISO 6876:2012 - Dentistry -- Root Canal Sealing Materials
Flow, working time and film thickness ISO 6876 testing is not applicable to root-end filling materials as expected. This is because MTA Repair HP is a root repair material, not a root canal sealer. In this particular situation, ISO 6876:2012 - "Dentistry – Root canal sealing materials" is used as guide to determine properties such as setting time, radiopacity, and solubility. These test results are consistent with the
8
intended use of root repair materials, because if the material is too fluid there is no possibility to seal the lateral of a root perforation without experiencing the flowing of the cement and, consequently the loss of the material.
Bench test results allowed us to conclude that MTA Repair HP is well suited for its intended use.
Substantial Equivalence:
The subject and the predicate device are substantially equivalent based on identical indications for use, same operating principle and similar material and design. MTA HP and MTA Angelus present the same components except for their radiopacifier. This new radiopacifier agent prevents the discoloration of the tooth, since CaWO4 in the subject device does not reduce when exposed to sunlight, as does Bi2O3 in the predicate device.
MTA HP comes also with a plasticizer in its liquid to improve the plasticity of the material. Physical chemistry and biocompatibility properties of the subject device have not been affected. However, both the substitution of the radiopacifier agent and the addition of the plasticizer into the liquid did not affect the critical properties (setting time, solubility and radiopacity) of MTA REPAIR HP. There is a one minute difference noted in the working time of the subject device, compared to its predicate; however, the time difference does not affect the usability of the subject device.
Conclusion:
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate device encompass the same range of physical dimensions, including setting time, solubility, biocompatibility and shelf life. The subject and predicate devices are packaged in similar materials and both are provided nonsterile. Any differences in the technological characteristics do not raise new concerns.
Angelus Industria De Productos Odontologicos has demonstrated that, for the purposes of FDA's regulation of medical devices, MTA Repair HP is substantially equivalent in indications and design principles to its predicate device MTA-Angelus.