(60 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a root canal filling material, with no mention of AI or ML.
No
The device is a filling material for permanent root canal obturation, which is a restorative procedure rather than a therapeutic one aimed at treating a disease or condition.
No
This device is a filling material used for permanent obturation of the root canal, which is a treatment rather than a diagnostic process.
No
The device description clearly states it is a two-part filling material packaged in plastic syringes with a syringe mixer and dispensing tip, indicating it is a physical material and associated hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the Sonendo Filling Material 5C is for permanent obturation of the root canal within the patient's body. It's a material used in vivo (within a living organism), not in vitro (in glass, or outside the body).
- The device description confirms it's a filling material. It's a substance that hardens within the root canal.
- The performance studies focus on biocompatibility and physical/mechanical properties. These are relevant for a material implanted in the body, not for a diagnostic test.
Therefore, based on the provided information, the Sonendo Filling Material 5C is a medical device used for treatment within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.
Product codes
KIF
Device Description
The Sonendo Filling Material 5C is a two-part filling material developed for permanent root canal filling. It is a water-soluble acrylate which is radiopaque and hardens with a chemical curing system. The Sonendo Filling Material 5C is packaged in plastic syringes with a syringe mixer and a dispensing tip. The syringe and dispensing tips are the only patient contacting devices packaged with the Sonendo Filling Material 5C and are commercially available.
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
Dental Professionals trained in endodontics.
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
Biocompatibility Testing: The biocompatibility evaluation for the Sonendo Filling Material 5C was conducted in accordance with ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry, Annex A, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The biocompatibility testing included Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute Toxicity, Genotoxicity, Intramuscular Implantation, and Material mediated pyrogenicity. The biocompatibility testing conducted demonstrates adequate biocompatibility for the Sonendo Filling Material 5C.
ISO 6876 Testing: Testing according to ISO 6876:2012 Dentistry - Root canal sealing materials was performed on the Sonendo Filling Material 5C and as compared to the predicate device, it was substantially equivalent to the device and met the physical/mechanical properties of the standard. Key results included: Flow (33.45 mm), Working Time (32.98 mm), Setting Time (60 minutes, 7 seconds), Film Thickness (5 μm), Solubility & Disintegration (2.03%, No disintegration), and Radio-opacity (3.10 mm Al).
Clinical Studies: No human clinical testing was conducted to support substantial equivalence.
Key Metrics
Flow (ISO 6876: 2012): 33.45 mm
Working Time (ISO 6876: 2012): 32.98 mm
Setting Time (ISO 6876: 2012): 60 minutes, 7 seconds
Film Thickness (ISO 6876: 2012): 5 μm
Solubility & Disintegration (ISO 6876:2012): 2.03%, No disintegration
Radio-opacity (ISO 6876:2012): 3.10 mm Al
Predicate Device(s)
EndoREZ Dual Cure, Ultradent Products, Inc., K071106
Reference Device(s)
Pulp Canal Sealer EWT, Sybron Dental Specialties, Inc., K152956
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
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August 27, 2021
Sonendo, Inc. Steve Ziemba Vice President, Regulatory Affairs & Quality Assurance 26061 Merit Circle, Suite 102 Laguna Hills, California 92653
Re: K211995
Trade/Device Name: Sonendo Filling Material 5C Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: June 24, 2021 Received: June 28, 2021
Dear Steve Ziemba:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211995
Device Name Sonendo Filling Material 5C
Indications for Use (Describe)
Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K211995 510(k) Summary
-
- Submitter:
Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills, California 92653
- Submitter:
| Contact Person: | Steven L. Ziémba |
|---|---|
| Telephone Number: | (949) 667-8151 |
| Fax Number: | (949) 305-5201 |
June 24, 2021 Date Prepared:
-
- Device:
| Name of Device: | Sonendo Filling Material 5C |
|---|---|
| Common Name: | Root Canal Filling Resin |
| Classification Name: | Root Canal Filling Resin, per 21 CFR § 872.3820 |
| Device Class: | II |
| Product Code: | KIF |
-
- Predicate Device:
| Primary Predicate: | EndoREZ Dual Cure, Ultradent Products, Inc., K071106, Product
Code KIF |
|--------------------|--------------------------------------------------------------------------------------|
| Reference Device: | Pulp Canal Sealer EWT, Sybron Dental Specialties, Inc.,
K152956, Product Code KIF |
4. Device Description
The Sonendo Filling Material 5C is a two-part filling material developed for permanent root canal filling. It is a water-soluble acrylate which is radiopaque and hardens with a chemical curing system. The Sonendo Filling Material 5C is packaged in plastic syringes with a syringe mixer and a dispensing tip. The syringe and dispensing tips are the only patient contacting devices packaged with the Sonendo Filling Material 5C and are commercially available.
-
- Statement of Intended Use:
The Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.
- Statement of Intended Use:
-
- Summary of Technological Characteristics with the Predicate Device
The technological characteristics of the subject Sonendo Filling Material 5C are similar to the predicate device, EndoREZ Dual Cure (K071106). There are no substantial technical or functional differences between the Sonendo Filling Material 5C and the predicate device in
- Summary of Technological Characteristics with the Predicate Device
4
terms of chemical composition, function and intended use. Both are root canal filling resins consisting of a catalyst and base packaged in individual syringes. See Table 1 below for technological characteristics and comparisons of the root canal filling resins.
| Element | Sonendo Filling
Material 5C
(Subject Device) | EndoREZ Dual Cure
(Predicate Device) | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Company | Sonendo, Inc. | Ultradent Products, Inc. | N/A |
| 510(k) | K211995 | K071106 | N/A |
| Indications for Use | The Sonendo Filling
Material 5C is intended
for permanent
obturation of the root
canal following root
canal treatment. | EndoRez is designed to be
used with EndoREZ Points
and/or gutta percha for the
filling of cleaned and shaped
root canals. EndoREZ, in
conjunction with a master cone
and accessory cones (as
needed), provides optimum
sealing. Although EndoREZ
Points are recommended,
EndoREZ may be used with all
conventional endodontic
obturation techniques. | Indicated for same
purpose - filling of root
canals. |
| Target Users | Dental Professionals
trained in endodontics. | Dental Professionals trained in
endodontics. | Same |
| Basic Chemical
Composition | Poly(ethylene glycol)
diacrylate, water, 5-
acrylamido-2,4,6-
triiodoisophthalic acid,
triethanolamine, sodium
hydroxide, potassium
persulfate | Diurethane dimethacrylate,
triethylene glycol
dimethacrylate,
organophosphine oxide,
benzoyl peroxide, radiopaque
agent | Similar - The predicate
device employs acrylate
monomers catalyzed by
a peroxide as does the
subject device. |
| Material
Compatibility | Biocompatibility profile
is similar to currently
marketed reference
dental filling material
and demonstrates no
increased risk with
respect to long-term
biological safety. | Meets Biocompatibility
Requirements of ISO 10993-1 | Same |
| Element | Sonendo Filling
Material 5C
(Subject Device) | EndoREZ Dual Cure
(Predicate Device) | Comparison |
| Flow
(ISO 6876: 2012) | 33.45 mm
≥ 17mm | 17.31 mm
≥ 17mm | Same - Passed ISO
6876 test requirements |
| Working Time
(ISO 6876: 2012) | 32.98 mm
≥ 17mm | 17.38 mm
≥ 17mm | Same - Passed ISO
6876 test requirements |
| Setting Time
(ISO 6876: 2012) | 60 minutes, 7 seconds
Claim of 1 - 24 hours
Between 1 - 24 hours | 25 minutes, 46 seconds
Claim of 30 minutes
No more than 10% longer | Same - Passed ISO
6876 test requirements |
| Film Thickness
(ISO 6876: 2012) | 5 μm
≤ 50 μm | 5 μm
≤ 50 μm | Same - Passed ISO
6876 test requirements |
| Solubility &
Disintegration
(ISO 6876:2012) | 2.03%
No disintegration
≤ 3.0% by mass
No Disintegration | 0.77%
No disintegration
≤ 3.0% by mass
No Disintegration | Same - Passed ISO
6876 test requirements |
| Radio-opacity
(ISO 6876:2012) | 3.10 mm Al
≥ 3 mm of Aluminum | 6.6 mm Al
≥ 3 mm of Aluminum | Same - Passed ISO
6876 test requirements |
Table 1: Comparison of Subject and Predicate Devices
5
7. Performance Data
Biocompatibility Testing
The biocompatibility evaluation for the Sonendo Filling Material 5C was conducted in accordance with ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry, Annex A, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The biocompatibility testing included the following tests:
-
- Cytotoxicity
-
- Sensitization
-
- Intracutaneous Reactivity
6
-
- Acute Systemic Toxicity
-
- Subacute Toxicity
-
- Genotoxicity
-
- Intramuscular Implantation
-
- Material mediated pyrogenicity
The biocompatibility testing conducted demonstrates adequate biocompatibility for the Sonendo Filling Material 5C.
ISO 6876 Testing
Testing according to ISO 6876:2012 Dentistry - Root canal sealing materials was performed on the Sonendo Filling Material 5C and as compared to the predicate device, it was substantially equivalent to the device and met the physical/mechanical properties of the standard.
Clinical Studies
No human clinical testing was conducted to support substantial equivalence.
8. Conclusion as to Substantial Equivalence
The similarities in chemical composition, function and intended use of the Sonendo Filling Material 5C with the legally marketed predicate device, EndoREZ Dual Cure (K071106), support substantial equivalence.