(133 days)
KJJ, K060335
No
The device description and performance studies focus on the chemical and physical properties of the sodium hypochlorite solutions, with no mention of AI or ML.
No
The device is described as an irrigant, not a therapeutic agent that treats a disease directly.
No
Explanation: The device is used for irrigating, instrumentation, and debriding of root canal preparations, which are treatment procedures, not diagnostic ones. Performance studies are related to chemical properties and physical behavior in root canals, not the detection or identification of disease.
No
The device description explicitly states the products are "aqueous solutions," indicating they are physical substances (liquids) and not software. The performance studies also focus on physical properties like concentration, pH, viscosity, and wettability.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "irrigating, instrumentation and debriding of root canal preparations." This is a procedure performed on the patient's body (specifically, within the root canal), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is an aqueous solution of sodium hypochlorite used for endodontic procedures. This is a therapeutic/procedural agent, not a diagnostic test.
- Lack of Diagnostic Purpose: The description focuses on the physical actions of the solution (irrigating, debriding, lubrication, flow control, penetration) within the root canal, not on detecting or measuring any substance or characteristic to diagnose a disease or condition.
IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
ChlorCid, ChlorCid V and ChlorCid Surf are used for irrigating, instrumentation and debriding of root canal preparations.
Product codes
KJJ
Device Description
The ChlorCid family of products are aqueous solutions of 3% sodium hypochlorite used for endodontic procedures. When desired, ChlorCid V is a more viscous solution for enhanced flow control and lubrication, and ChlorCid Surf includes a surfactant which assists in the product's ability to penetrate in tight canal spaces.
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
Testing to demonstrate equivalence with the predicate included a sodium hypochlorite assay, pH, viscosity, and contact angle (measure of wettability; used on the surfactant-containing solutions). These tests show that ChlorCid, ChlorCid V, and ChlorCid Surf have the same concentration of sodium hypochlorite, the same pH, and include a similar surfactant for the same reason (wettability/penetrability). ChlorCid V also contains a small amount of thickener (
N/A
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 9, 2018
Ultradent Products, Inc. Corey Jaseph Regulatory Affairs Manager 505 W Ultradent Drive (10200 South) South Jordan, Utah 84095
Re: K173163
Trade/Device Name: ChlorCid, ChlorCid V, ChlorCid Surf Regulatory Class: Unclassified Product Code: KJJ Dated: January 9, 2018 Received: January 11, 2018
Dear Corey Jaseph:
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 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);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173163
Device Name
ChlorCid family - ChlorCid, ChlorCid V, ChlorCid Surf
Indications for Use (Describe)
ChlorCid, ChlorCid V and ChlorCid Surf are used for irrigating, instrumentation and debriding of root canal preparations.
| 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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Image /page/3/Picture/0 description: The image shows a logo in brown color. The logo appears to be a stylized representation of the letters 'U' and 'F' combined into a single, interconnected shape. The 'U' is on the left, and the 'F' is formed by a horizontal line extending from the top right of the 'U' and another shorter horizontal line in the middle. There is a trademark symbol in the upper right corner of the logo.
Traditional 510(k) Summary
This summary of substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 for the ChlorCid® family of products.
I. Applicant's Name and Address
Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095
| Contact Person: | Ms. Corey Jaseph, MS, RAC |
|---|---|
| Title: | Regulatory Affairs Manager |
| Telephone: | 800-553-4420 |
| Fax: | 801-553-4609 |
Date Summary Prepared: February 5, 2018
II. Name of the Device
| Trade Name: | ChlorCid, ChlorCid V, ChlorCid Surf |
|---|---|
| Common Name: | Cleanser, Root Canal |
| Device Classification: | Unclassified |
| Classification Product Code: | KJJ |
| Regulation Number: | Pre-amendment device |
III. Device Description
The ChlorCid family of products are aqueous solutions of 3% sodium hypochlorite used for endodontic procedures. When desired, ChlorCid V is a more viscous solution for enhanced flow control and lubrication, and ChlorCid Surf includes a surfactant which assists in the product's ability to penetrate in tight canal spaces.
IV. Indications for Use
ChlorCid, ChlorCid V and ChlorCid Surf are used for irrigating, instrumentation and debriding of root canal preparations.
V. Predicate Device
The predicate devices, ChlorXtra and 3% NaOCL, are cleared under 510(k) K082470 and are legally manufactured and distributed by Inter-Med, Inc and Vista-Dental, Inc.; 2200 Northwestern Ave, Racine, WI 53404.
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VII. Comparison of Technological Characteristics
Predicate technological comparison:
The technology, delivery, and intended use of the ChlorCid family of products are substantially equivalent to the identified predicates as outlined in Table 12-1:
| Ultradent 510(k) Submission | Predicate Device: K082470 | ||||
|---|---|---|---|---|---|
| ChlorCid | ChlorCid V | ChlorCid S | Vista 3% | ||
| NaOCL | Vista | ||||
| ChlorXtra | |||||
| Indications for Use | ChlorCid, ChlorCid V and ChlorCid Sur are | ||||
| used for irrigating, cleaning, | |||||
| instrumentation, and debriding of root | |||||
| canal preparations. | Sodium hypochlorite 3% & 6% | ||||
| solution and Sodium Hypochlorite | |||||
| 6% with wetting agents to lower | |||||
| surface tension marketed as Chlor- | |||||
| Xtra are solutions used for the | |||||
| debridement and in the | |||||
| instrumentation of root canal. | |||||
| Sodium hypochlorite 3% & 6% and | |||||
| Chlor-Xtra are sodium hypochlorite | |||||
| solutions in water. | |||||
| Sodium | |||||
| Hypochlorite | |||||
| Concentration | 3% | 3% | 3% | 3% | 6% |
| Surfactant | None | None | Sodium | ||
| alkanoate | |||||
| (compatible | |||||
| with chlorine, | |||||
| biodegradable) | None | Triton X-100 | |||
| Containers | 30 mL | ||||
| container | |||||
| used with | |||||
| disposable | |||||
| syringes, 16 | |||||
| oz bottle | 30 mL | ||||
| container | |||||
| used with | |||||
| disposable | |||||
| syringes | 30 mL | ||||
| container used | |||||
| with | |||||
| disposable | |||||
| syringes, 16 oz | |||||
| bottle | 3 and 5 mL | ||||
| pre-filled | |||||
| syringes, 16 | |||||
| oz bottle | 3 and 5 mL | ||||
| pre-filled | |||||
| syringes, 16 | |||||
| oz bottle | |||||
| pH | 11.8 | 12.7 | 12.2 | 11.5 | 12.7 |
| Contact Angle | |||||
| (wettability) | 26.6 ± 0.4 | Analysis | |||
| Not Done | 20.3 ± 0.7 | Analysis Not | |||
| Done | 22.5 ± 2.4 | ||||
| Viscosity (cP) | 13.5 | 96.8 | 16.1 | Not done | Not done |
| Biocompatibility | Literature | Literature | Literature | Literature | Literature |
The ChlorCid family of products are substantially equivalent to the identified predicate with respect to intended use, sodium hypochlorite concentration, presence of a surface acting agent (surfactant), pH, and biocompatibility. Although the indications for use statement are not
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exactly the same, as the predicate discusses the composition and the ChlorCid family does not, in fact, the composition is substantially similarly including the use of a surface-active agent in one product variation. Finally, the uses of the predicate and ChlorCid products are the same, for debriding and irrigating root canals.
Testing to demonstrate equivalence with the predicate included a sodium hypochlorite assay, pH, viscosity, and contact angle (measure of wettability; used on the surfactant-containing solutions). These tests show that ChlorCid, ChlorCid V, and ChlorCid Surf have the same concentration of sodium hypochlorite, the same pH, and include a similar surfactant for the same reason (wettability/penetrability). ChlorCid V also contains a small amount of thickener (