(237 days)
Not Found
No
The description focuses on the chemical composition and application method of a gel cleanser, with no mention of AI or ML technologies.
No
The device is a gel cleanser intended to clean tooth cavities, not to treat or cure a disease or condition. Its purpose is preparatory to a bonding procedure.
No
The device is described as a gel cleanser for cleaning a tooth cavity prior to bonding procedures, not for identifying a disease or condition. Its purpose is preparatory, not diagnostic.
No
The device is a gel cleanser, which is a physical substance applied to a tooth, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures." This is a direct application to a patient's tooth for a therapeutic or restorative purpose, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a gel applied to a tooth cavity, rinsed, and followed by a bonding procedure. This is a dental procedure performed directly on the patient.
- Anatomical Site: The anatomical site is the "interior of a prepared cavity of a tooth," which is part of the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting for testing purposes.
IVD devices are used to perform tests on specimens taken from the human body to provide information about a person's health. This device is used directly on the patient's tooth as part of a dental treatment.
N/A
Intended Use / Indications for Use
Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.
Product codes (comma separated list FDA assigned to the subject device)
LBH, KLE
Device Description
Papacarie Duo is a light blue colored gel cleanser dispensed from a prefilled, multi-use syringe storage system to a mixing pad, then applied to the interior of a prepared tooth cavity by dental professionals using a flocked tip brush or micro brush (not included). The tooth cavity is rinsed with water 60 seconds after application and prior to application of self-etch bonding material. The formula has a light blue color for easier visualization when it is applied on tooth surfaces. For single application prior to self-etch bonding procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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)
Non-clinical performance tests were conducted according to ISO 29022:2013 using Papacarie DUO to demonstrate substantial equivalence to the predicate device, and cleaning of prepared tooth surfaces prior to bonding of restorations.
Biocompatibility of Papacarie Duo was demonstrated and the data provided in this submission according to ISO 10993-1:2018.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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.
July 18, 2024
Elevate Oral Care Steven Pardue Managing Member 346 Pike Rd Suite 5 West Palm Beach, Florida 33411
Re: K233768
Trade/Device Name: Papacarie Duo Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH, KLE Dated: [NOTE: Use date of most recent supplement] Received: June 18, 2024
Dear Steven 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
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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
Submission Number (if known)
Device Name
Papacarie Duo
Indications for Use (Describe)
Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.
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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Image /page/4/Picture/0 description: The image is a logo for Elevate Oral Care. The logo features a teal-colored globe on the left side, with white lines dividing the globe into sections. To the right of the globe is the word "elevate" in a teal, sans-serif font. Below "elevate" is the phrase "ORAL CARE" in a smaller, also teal, sans-serif font, with a registered trademark symbol.
510(k) Summary: K233768
Submitter:
| Company: | Elevate Oral Care |
|---|---|
| Street: | 346 Pike Road, Suite 5 |
| City, State Zip: | West Palm Beach, FL 33411 |
| Country: | USA |
| Correspondent: | Steve Pardue |
| Managing Member | |
| Phone: | 877-866-9113 |
| Fax: | 561-244-1927 |
| Email: | spardue@elevateoralcare.com |
| Date: | July 18 2024 |
Name of Device
| Proprietary Name: | Papacarie™ Duo |
|---|---|
| Classification Name: | Varnish, Cavity |
| 21 CFR 872.3260 as Class II device | |
| Product Code: LBH, KLE | |
| Common Name: | Cavity Varnish |
Predicate Devices
| Predicate Device | 510(k) | Product Code |
|---|---|---|
| FiteBac Cavity Cleanser | K190271 | LBH |
| Clean and Boost Dentin & | ||
| Enamel Cleanser | K120620 | KLE |
Description
Papacarie Duo is a light blue colored gel cleanser dispensed from a prefilled, multi-use syringe storage system to a mixing pad, then applied to the interior of a prepared tooth cavity by dental professionals using a flocked tip brush or micro brush (not included). The tooth cavity is rinsed with water 60 seconds after application and prior to application of self-etch bonding material. The formula has a light blue color for easier visualization when it is applied on tooth surfaces. For single application prior to self-etch bonding procedure.
Indications for Use
Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.
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| Comparison of the Indication for Use of Papacarie Duo to the Predicate Devices | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| Papacarie Duo
Indication for Use | Clean & Boost Dentin &
Enamel Cleanser, Indication for
Use, K120620 | FiteBac Cavity Cleanser |
|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Papacarie Duo is a gel
cleanser intended to
clean the interior of a
prepared cavity of a
tooth prior to self-etch
bonding procedures. | Clean and Boost is an acidic,
aqueous cleanser that has been
designed to help remove
contaminants from the surface of a
tooth prior to bonding. These
contaminants can be hand piece
oil, tooth debris, or imaging
powder (used to create digital
impressions for CAD/CAM
restorations). | The FiteBac® Cavity Cleanser
is a 2% K21 QAS aqueous
ethanolic solution intended for
cleansing and
moistening/rewetting of cavity
preparations. |
Technological Characteristics
The chemical composition of Papacarie Duo, while different than the predicate devices has the same intended function as both predicate devices, to clean the prepared cavity in a tooth. The use for Papacarie Duo is highly similar to the predicates indications for use as both devices are used in a prepared cavity in a tooth prior to bonding as part of tooth restoration procedures and any differences do not raise concerns of safety or effectiveness.
The predicate device Clean and Boost uses strong acid to clean prepared cavities while the second predicate device uses ethanol and quaternary ammonium silane to clean surfaces. All products use different technological methods to clean prepared tooth surfaces. Papacarie Duo uses papain and propylene glycol as cleansers to clean these surfaces. These different technological characteristics do not present different questions of safety and effectiveness.
Papain has been used in food preparation and as ingredients and is considered GRAS for these uses.
Summary of Non-Clinical Performance Tests
Non-clinical performance tests were conducted according to ISO 29022:2013 using Papacarie DUO to demonstrate substantial equivalence to the predicate device, and cleaning of prepared tooth surfaces prior to bonding of restorations.
Biocompatibility of Papacarie Duo was demonstrated and the data provided in this submission according to ISO 10993-1:2018.
Conclusions
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Based on the comparison of indications for use, technological characteristics and non-clinical performance testing, we believe that Papacarie Duo is substantially equivalent to the predicate device Clean and Boost and FiteBac Cavity Cleanser.