(325 days)
No
The device description and performance studies focus on the chemical and physical properties of the liquid treatment for dentin hypersensitivity, with no mention of AI or ML.
Yes
The device is intended for the "Treatment of Dental Hypersensitivity" and "will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity," which aligns with the definition of a therapeutic device as it directly treats a condition.
No
The device is described as a "treatment for dentin hypersensitivity" and is intended to "provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity." There is no mention of it diagnosing any condition.
No
The device description clearly states it is a "two-part liquid" and describes its application using physical items like dropper bottles, mixing wells, and applicator brushes. This indicates a physical product, not software.
Based on the provided information, Black Diamond is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Treatment of Dental Hypersensitivity." This is a therapeutic treatment applied directly to the patient's teeth (in vivo), not a test performed on a sample taken from the body (in vitro) to diagnose a condition.
- Device Description: The description details a two-part liquid applied to the tooth surface to occlude dentinal tubules. This is a physical treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical effect of the device (occlusion of dentinal tubules) and comparison to a predicate device with a similar therapeutic function, not on diagnostic accuracy metrics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Black Diamond's function is to treat a symptom (hypersensitivity) by physically altering the tooth structure, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
Product codes
PHR
Device Description
Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity.
The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or may not be included in the product package. These are standard items in dental offices and numerous types of each will work.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin
Indicated Patient Age Range
Adults over the age of 21.
Intended User / Care Setting
Dental offices
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
A hydraulic conductance test was completed showing the efficacy of Black Diamond in occlusion of dentinal tubules in comparison to the predicate device. Additionally, SEM images were taken of untreated dentin treated with the predicate and subject device to show dentin tubule occlusion, and no other effect on healthy dentin.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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June 23, 2023
Elevate Oral Care, LLC % Steve Pardue Elevate Oral Care 346 Pike Road Suite 5 West Palm Beach, Florida 33411
Re: K222323
Trade/Device Name: Black Diamond Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: PHR Dated: June 8, 2023 Received: June 8, 2023
Dear Steve Pardue:
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
1
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) 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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., CQIA 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
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Indications for Use
510(k) Number (if known) K222323
Device Name Black Diamond
Indications for Use (Describe)
Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
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 the logo for Elevate Oral Care. The logo consists of a blue globe-like icon on the left, followed by the word "elevate" in blue, and the words "ORAL CARE" in a smaller font size below it. The logo is simple and clean, with a focus on the company name and its connection to oral health.
510(k) Summary
Submitter:
346 Pike Road, Suite 5 · Vest Palm Beach, FL 33411 Phone: 877-866-9113 · Fax: 561-244-1927 www.elevateoralcare.com
K22323
| Company: | Elevate Oral Care |
|---|---|
| Street: | 346 Pike Road, Suite 5 |
| City, State Zip: | West Palm Beach, FL 33411 |
| Country: | USA |
| Estab. Registration #: | 3009603151 |
| Correspondent: | Steve Pardue |
| Managing Member | |
| Phone: | 877-866-9113 |
| Fax: | 561-244-1927 |
| Email: | spardue@elevateoralcare.com |
| Date: | October 26, 2022 |
Name of Device
| Proprietary Name: | Black Diamond™ |
|---|---|
| Classification Name: | Silver Fluoride Dental Hypersensitivity Varnish |
| 21 CFR 872.3260 as Class II device | |
| Product Code: PHR | |
| Common Name: | Silver Fluoride Dental Hypersensitivity Varnish & Device |
Predicate Devices
| Primary Predicate Device | 510(k) |
|---|---|
| Silver Dental Arrest | K102973 |
| Reference Device | |
| Riva Star | K172047 |
Description
Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity.
The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or
4
may not be included in the product package. These are standard items in dental offices and numerous types of each will work.
Indications for Use
- . Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in patients over the age of 21.
Comparison of the Intended Use of Black Diamond to the Predicate Device
| Black Diamond Indication for Use | Silver Dental Arrest |
|---|---|
| Treatment of Dental Hypersensitivity. For use | |
| in adults over the age of 21. | Treatment of Dental Hypersensitivity. For use |
| in adults over the age of 21. |
Comparison of the Intended Use of Black Diamond to the Reference Device
| Black Diamond
| Indication for Use | Riva Star |
|---|---|
| Treatment of Dental | |
| Hypersensitivity. For | |
| use in adults over the | |
| age of 21. | Treatment of Dental |
| Hypersensitivity. | |
| For use in adults | |
| over the age of 21. |
Technological Characteristics
Black Diamond has similar composition and claims as the predicate device Silver Dental Arrest and reference product Riva Star (product codes PHR). All three devices contain silver and fluoride as the main functioning ingredient.
Black Diamond uses an aqueous solution of silver fluoride, followed by a second solution of Stannous Fluoride, a reducing agent, that causes the deposition of silver into open dentinal tubules which in turns reduces sensitivity and hydraulic conductance. This same silver deposition process is used by the predicate device as well as the reference device, both in product code PHR.
Black Diamond has been commercially available in various countries for many years with a significant safe history of use as well as a published body of literature.
Application of Black Diamond is similar to both other products in product code PHR.
Summary of Physical Tests
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A hydraulic conductance test was completed showing the efficacy of Black Diamond in occlusion of dentinal tubules in comparison to the predicate device. Additionally, SEM images were taken of untreated dentin treated with the predicate and subject device to show dentin tubule occlusion, and no other effect on healthy dentin.
It was concluded that Black Diamond is substantially equivalent to the predicate device, and reference device, and is a two-part liquid intended as a treatment for dentin hypersensitivity for use in patients over the age of 21.
Description of Safety and Substantial Equivalence
The chemical components in Black Diamond have been used extensively in dental devices and have significant toxicological profiles and safety history. Biocompatibility and Risk assessments have been completed on the product, ingredients, and combination of ingredients. Ion elution tests have been successfully completed. These facts support the compatibility of Black Diamond, and the safety of the applicant device is substantially equivalent to the predicate devices in properties, intended use and composition.
Information provided in this submission confirms the substantial equivalence to the predicate devices with common indications, and indication from the reference predicate devices. The data provided in this 510(k) submission also shows that the composition is safe for its intended use based on the biocompatibility assessment and risk assessment conducted according to ISO 10993-1 and ISO 14971.