(82 days)
The MTA2 ROOT AND PULP MATERIALS are intended for use in dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
The MTA2 ROOT AND PULP MATERIALS are designed and developed for dentists to use in dental procedures that contact with vital pulp tissue and periradicular tissue, as well as obturation and sealing of root canals. The MTA2 ROOT AND PULP MATERIALS can be used for dental procedures such as: pulp capping, cavity lining, base material in a cavity, pulpotomies, root-end filling, apexification, perforation repair, root resorption, and sealing/obturation. The dentist mixes the powder with the provided gel and places the mixed MTA2 material into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. The MTA2 ROOT AND PULP MATERIALS are available in white or gray.
The provided text describes the 510(k) summary for a dental device, the MTA2 ROOT AND PULP MATERIALS. This device is a cement primarily used for root canal procedures and interaction with pulp and periradicular tissues.
Here's an analysis of the acceptance criteria and supporting study details based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance (MTA2 ROOT AND PULP MATERIALS) |
|---|---|
| ADA 57 (Radiopacity) | Met the ADA 57 standard |
| ADA 57 (Solubility) | Met the ADA 57 standard |
| ADA 57 (Dimensional Stability) | Met the ADA 57 standard |
| ADA 57 (Film Thickness) | Met the ADA 57 standard |
| ADA 57 (Flow) | Met the ADA 57 standard |
| ADA 57 (Working Time) | Performed to measure, compared to predicates (results not explicitly stated but implied meeting similar performance) |
| ADA 57 (Setting Time) | Performed to measure, compared to predicates (results not explicitly stated but implied meeting similar performance) |
| ISO 9917 (Compressive Strength) | Tests performed to show conformance to ISO 9917 |
| ISO 9917 (Leaching of Arsenic) | Tests performed to show conformance to ISO 9917 |
| ISO 9917 (Leaching of Lead) | Tests performed to show conformance to ISO 9917 |
| Biocompatibility (Cytotoxicity) | Evaluated (with the gel) |
| Biocompatibility (Implantation Tests) | Evaluated (with the gel) |
| Compositional Analysis (X-ray diffraction) | Performed |
| Compositional Analysis (X-ray fluorescence) | Performed |
| Washout | Performed |
| Particle Size Analysis | Performed |
| Hydroxyapatite Formation | Performed (induced precipitation of hydroxyapatite crystals in synthetic body fluid) |
| Substantial Equivalence to Predicate K011009 (White MTA Material) | Demonstrated through bench testing and similarities in inorganic powder composition, hydration mechanism, and intended use for pulp/periapical tissue contact. |
| Substantial Equivalence to Predicate K080203 (MTA root canal sealer) | Demonstrated through bench testing and similarities in inorganic powder composition, hydration mechanism, and intended use for sealing/obturation of root canals, including presence of a gel. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance (bench testing). There is no information provided about a "test set" in the context of human subjects or a clinical study. The data provenance is laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device's evaluation was based on non-clinical, bench testing against recognized standards (ADA 57, ISO 9917). There was no "test set" requiring expert ground truth in the traditional sense of diagnostic accuracy studies. The standards themselves serve as the 'ground truth' for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Without a clinical test set or expert evaluation component, there is no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/CAD device. It is a dental material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was established by adherence to recognized international and national standards for dental materials: ADA 57, ISO 6876, and ISO 9917. These standards define the acceptable physical, chemical, and biological properties for such materials.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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K12289Z
510(k) Summary
per 21CFR807.92
CONTACT:
Carolyn Primus. Consultant to Avalon Biomed Inc. 7282 55th Ave E # 227 Bradenton, FL 34203 USA www.AvalonBiomed.com Phone: (941) 753-9737 Fax: (941) 753-8778 E-mail: info@avalonbiomed.com DATE PREPARED: November 27, 2012
TRADE OR PROPRIETARY NAME: MTA2 ROOT AND PULP MATERIALS CLASSIFICATION NAME: Root Canal Filling Resin 872.3820
PREDICATE DEVICES: K011009, White MTA Material and K080203, MTA root canal sealer DEVICE DESCRIPTION: The MTA2 ROOT AND PULP MATERIALS are designed and developed for dentists to use in dental procedures that contact with vital pulp tissue and periradicular tissue, as well as obturation and sealing of root canals. The MTA2 ROOT AND PULP MATERIALS can be used for dental procedures such as: pulp capping, cavity lining, base material in a cavity, pulpotomies, root-end filling, apexification, perforation repair, root resorption, and sealing/obturation.
The dentist mixes the powder with the provided gel and places the mixed MTA2 material into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. The MTA2 ROOT AND PULP MATERIALS are available in white or gray.
INTENDED USE: The MTA2 ROOT AND PULP MATERIALS are intended for use in dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
TECHNOLOGICAL CHARACTERISTICS: The MTA2 ROOT AND PULP MATERIALS are primarily hydraulic tricalcium silicate powders that are substantially similar to the powders in White MTA material (K011009) and MTA root canal sealer (K080203), which are also primarily tricalcium silicate cements. The tricalcium silicate-based materials are known to set with water into a hard substance, containing calcium hydroxide dispersed among the hydrated particles of tricalcium silicates. Both the MTA2 MATERIALS and the predicate devices are made radiopaque by adding Bi203 powder during manufacturing. COMPARISONS TO PREDICATES: We believe the MTA2 ROOT AND PULP MATERIALS are substantially equivalent to the WHITE MTA MATERIAL (K011009), when used for contact with pulp tissue and periapical tissue, and substantially equivalent to MTA root canal sealer (K080203). when used as a root canal sealer.
Similarities: The predicates (White MTA Material & MTA root canal sealer) and the MTA2 ROOT AND PULP MATERIALS are based on an inorganic powder composed of primarily tricalcium silicate, dicalcium silicate, and bismuth oxide. The predicates and the MTA2 ROOT AND PULP MATERIALS rely on water to hydrate the calcium silicate phases, and cause setting into a hard substance containing hydrated silicates and some calcium hvdroxide.
Both the MTA2 ROOT AND PULP MATERIALS and the predicate White MTA Material are used in root canals or on vital pulp tissue. Both the MTA2 ROOT AND PULP MATERIALS
DEC 1 1 2012
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and the predicate MTA root canal sealer are used for sealing and obturation of root canals. The predicate MTA root canal sealer and the MTA2 ROOT AND PULP MATERIALS are similar because both kits contain a gel.
The new and predicate materials had similar compositions, radiopacity, film thickness, flow and compressive strengths, when mixed at similar powder to liquid/gel ratios. Both MTA2 MATERIALS and the predicate materials induce the precipitation of hydroxyapatite crystals in synthetic body fluid.
Differences: Both a white version and a gray version of MTA2 ROOT AND PULP MATERIALS will be offered, whereas the White MTA predicate is whitish and the MTA root canal sealer is vellowish. However gray forms of MTA have also been considered substantially equivalent (such as K96174, K980332, and K981620).
The predicate White MTA Material and MTA root canal sealer differ from the MTA2 ROOT AND PULP MATERIALS differ because the MTA2 ROOT AND PULP MATERIALS contain a finer powder.
The predicates White MTA Material and the MTA2 ROOT AND PULP MATERIALS differ because the MTA2 ROOT AND PULP MATERIALS kits will contain a gel to create the consistency desired. The predicate White MTA kit contains only water; however, the predicate MTA root canal sealer (K080203) has a gel.
The predicate White MTA Material and the MTA2 ROOT AND PULP MATERIALS differ because the MTA2 ROOT AND PULP MATERIALS are suitable for use as a sealer, meeting the requirements of ADA 57. The predicates (White MTA Material and the MTA root canal sealer) differ from the gray form of MTA2 ROOT AND PULP MATERIALS differ because the gray form contains an additional component.
NON-CLINICAL PERFORMANCE: MTA2 ROOT AND PULP MATERIALS met the ADA 57 standard for radiopacity, solubility, dimensional stability, film thickness, and flow. The ADA 57 tests were also performed to measure the working time and setting time of MTA2 compared to the predicates. Tests for compressive strength and leaching of arsenic and lead were performed to shown conformance to ISO 9917. Analyses of the compositions were performed by x-ray diffraction and x-ray fluorescence. Washout, particle size analysis, and hydroxyapatite formation tests were also performed.
The MTA2 ROOT AND PULP MATERIALS were evaluated for biocompatibility with the gel in cytotoxicity and implantation tests.
CLINICAL PERFORMANCE: No clinical tests were performed in the development of the MTA2 ROOT AND PULP MATERIALS.
SUBSTANTIAL EQUIVALENCE: Bench testing was performed to ensure biocompatibility and that the requirements were achieved to conform to the FDA recognized standards ADA 57, ISO 6876, and appropriate requirements of ISO 9917.
We believe that the performance data provided herein demonstrate that MTA2 ROOT AND PULP MATERIALS are substantially equivalent to the predicates in design, principle of performance, technology, and composition. We believe the MTA2 ROOT AND PULP MATERIALS perform as well as or better than the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 11, 2012
Ms. Carolyn M. Primus President Avalon Biomed Incorporated 7282 55th Avenue E # 227 Bradenton, Florida 34203
Re: K122892
Trade/Device Name: MTA2 Root And Pulp Materials Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: November 12, 2012 Received: November 19, 2012
Dear Ms. Primus:
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.
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Page 2 - Ms. Primus
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K122892
Device Name: MTA2 ROOT AND PULP MATERIALS
Indications For Use: The MTA2 ROOT AND PULP MATERIALS are intended for use in dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals!
2012.12.11
15:00:24
Susan Runner DDS, MA
-05'00'
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number;
Prescription Use × (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) Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Premarket Notification-Updated Avalon Biomed Inc. K122892: MTA2 ROOT AND PULP MATERIALS November 20, 2012
Page 15 of 75
§ 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.