(96 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a root canal obturation paste, with no mention of AI or ML.
Yes
The device is described as a "permanent obturation of the root canal following root canal treatment," which directly addresses the function of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is a material for permanent obturation of the root canal, described as an injectable paste that hardens to fill the root canal, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "single component injectable paste material" comprised of physical substances (alginate and a calcium containing compound) and is packaged in a syringe or capsule, indicating it is a physical material/device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Permanent obturation of the root canal following root canal treatment." This describes a material used within the body to fill a physical space, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a material (paste) that is injected into the root canal and hardens. This is a therapeutic or restorative device, not a diagnostic one.
- Anatomical Site: The anatomical site is the "Root canal," which is a part of the body where the device is placed, not a source of a sample for testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
In summary, the device is a material used for a dental procedure (root canal obturation), which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Permanent obturation of the root canal following root canal treatment.
Product codes
KIF
Device Description
Sonendo Material A is a single component injectable paste material intended for permanent obturation of the root canal following root canal treatment. The device is comprised of alginate and a calcium containing compound which crosslinks in the presence of water to form an insoluble polymer. The placement into the root canal can be accomplished with or without the use a root canal point. The material is radiopaque and has physical properties such that it is suitable for root canal obturation. The material is packaged in either a syringe with single use dispensing tips or in a single dose capsule.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
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)
Sonendo Material A has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot SP Root Canal Sealer. Bench tests include: flow, working time, setting time, film thickness, solubility, and radiopacity in alignment with ISO 6876.
Biocompatibility test results demonstrate that Sonendo Material A is non-mutagenic, non-cytotoxic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
iRoot SP Root Canal Sealer (K080917)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
October 22, 2018
Sonendo, Inc. Eric Simon Director of Regulatory Affairs and Quality Assurance, Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills, California 92653
Re: K181922
Trade/Device Name: Sonendo Material A Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: July 17, 2018 Received: July 18, 2018
Dear Eric Simon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S3
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K181922 |
|---|---|
| Device Name | Sonendo Material A |
| Indications for Use (Describe) | Permanent obturation of the root canal following root canal treatment. |
| 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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3
7.0 510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Sonendo, Inc. |
|---|---|
| DATE PREPARED: | July 17, 2018 |
| CONTACT PERSON: | Eric Simon |
| 26061 Merit Circle, Suite 102 | |
| Laguna Hills, CA 92653 | |
| Phone: 949.766.3636 | |
| Fax: 949.305.5201 | |
| TRADE NAME: | Sonendo Material A |
| COMMON NAME: | Resin, Root Canal Filling |
| CLASSIFICATION NAME: | Root canal filling resin |
| DEVICE CLASSIFICATION: | Class 2, per 21 CFR 872.3820 |
| REVIEWING PANEL: | Dental |
| ESTABLISHMENT REGISTRATION NO. | 3010817521 |
| PRODUCT CODE | KIF |
PREDICATE DEVICES: iRoot SP Root Canal Sealer (K080917)
Substantially Equivalent To:
The Sonendo Material A is substantially equivalent in intended use, principle of operation and technological characteristics to the iRoot Canal Sealer (K080917).
Description of the Device Subject to Premarket Notification:
Sonendo Material A is a single component injectable paste material intended for permanent obturation of the root canal following root canal treatment. The device is comprised of alginate and a calcium containing compound which crosslinks in the presence of water to form an insoluble polymer. The placement into the root canal can be accomplished with or without the use a root canal point. The material is radiopaque and has physical properties such that it is suitable for root canal obturation. The material is packaged in either a syringe with single use dispensing tips or in a single dose capsule.
4
Indication for Use:
Permanent obturation of the root canal following root canal treatment.
Device Comparison Table:
| | Sonendo
Material A
(Subject
Device) | iRoot SP Root Canal
Sealer (Predicate
Device - K080917) | Discussion/Justification of
Differences |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication
for Use | Permanent
obturation of the
root canal
following root
canal treatment | Permanent obturation of the
root canal following vital
pulp-extirpation
Permanent obturation of the
root canal following
removal of infected or
necrotic pulp and placement
of intracanal dressings | Equivalent |
| Basic
Chemical
Composition | Sodium alginate,
glycerol, calcium
sulfate, calcium
tungstate, sodium
pyrophosphate,
polysorbate 60,
zinc oxide,
fumed silica,
ytterbium
fluoride, barium
borosilicate | Zirconium oxide, dicalcium
silicate, calcium hydroxide,
calcium phosphate
monobasic, filler, thickening
agent | iRoot SP Root Canal Sealer was
identified as the predicate device due to
the subject device having similar
materials and delivery form (i.e.
premixed ready-to-use injectable paste)
to the predicate. The predicate device is
composed of lubricants, a radiopaque
agent and thickening agents as does the
subject device. Results of bench and
biocompatibility testing completed in
alignment with ISO 6876 and ISO
10993-1, respectively demonstrate that
any material differences between the
subject device and predicate device do
not raise any new questions as to safety
and effectiveness. Therefore, it is
concluded that Sonendo Material A is
substantially equivalent to the predicate
device. |
| Standard | ISO 6876
ISO 10993-1 | ISO 6876
ISO 10993-1 | Equivalent |
| Treatment
Site | Root canal | Root Canal | Equivalent |
| Sterile | Non-sterile | Non-sterile | Equivalent |
| Packaging | Pre-loaded
syringe | Pre-loaded syringe | Equivalent |
Performance Data:
Sonendo Material A has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot SP Root Canal Sealer. Bench tests include: flow, working time, setting time, film thickness, solubility, and radiopacity in alignment with ISO 6876.
5
Biocompatibility test results demonstrate that Sonendo Material A is non-mutagenic, non-cytotoxic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.
Conclusion:
Sonendo Material A and its predicate device have the same intended use, provides similar chemical, physical and biocompatible properties, and comparable performance specifications to iRoot SP Root Canal Sealer. The subject and predicate devices are packaged in similar materials and utilize similar methods of application. Any differences in the technological characteristics do not raise new issues of safety or effectiveness.