(211 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the gel and its interaction with dentin, with no mention of AI or ML.
Yes.
The device is indicated for the reduction of tooth hypersensitivity and stimulates hydroxyapatite formation to occlude dentinal tubules, which are therapeutic actions.
No
The device description and intended use clearly state that Parkell® Desensitizer Gel is used for the treatment of tooth hypersensitivity, not its diagnosis. It alleviates symptoms and forms a protective layer.
No
The device description clearly states it is a "gel" and is packaged in a "syringe" with "tips and applicator brushes," indicating it is a physical substance and associated hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a treatment applied directly to the tooth/dentin to reduce hypersensitivity. This is a therapeutic application, not a diagnostic one.
- Device Description: The description explains how the gel works by releasing ions and forming hydroxyapatite to occlude dentinal tubules. This is a physical and chemical process happening in vivo (within the body), not an in vitro (outside the body) test to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue) to detect or measure substances, identify pathogens, or assess physiological states. The device is applied directly to the affected area for treatment.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:
- · treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion;
- · treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
- · treatment of tooth hypersensitivity associated with bleaching: and
- · treatment of prepared dentin for fillings and/or prosthetic restorations.
Product codes (comma separated list FDA assigned to the subject device)
EJK, LBH
Device Description
Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment sites. It is a gel which requires no mixing prior to use and which is applied to treatment sites using a standard applicator brush. Parkell® Desensitizer releases calcium and phosphate ions at the treatment site and stimulates hydroxyapatite formation on the surface of treated dentin and in dentinal tubules. In this manner, the Device hardens following application and forms a layer of mineral hydroxyapatite as well as hydroxyapatite plugs which occlude dentinal tubules, which results in the treatment of dental hypersensitivity.
Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth / dentin
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)
An evaluation of biocompatibility was conducted on Parkell® desensitizer in accordance, e.g., with ISO10993-1:2009, ISO10993-5:2009, ISO10993-10:2010, ISO10993-11:2017, ISO10993-12: 2012, and the FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016). The conclusion of the evaluation is that Parkell® Desensitizer Gel is biocompatible. In addition, an evaluation of the bioactivity of Parkell® desensitizer was performed through analysis of treated dental tissue and via tests performed in accordance with ISO23317:2014.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Microshear bond strength to dentin of resin-based bonding agents following pretreatment with Device or Predicate Device (Pass/fail criteria of at least about 15MPa):
Commercially-available bonding agent #1 [self-etch mode]: >=15MPa
Commercially-available bonding agent #1 [total-etch mode]: >=15MPa
Commercially-available bonding agent #2 [self-etch mode]: >=15MPa
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
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.
0
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 and Human Services logo. To the right of that 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.
November 22, 2019
Parkell, Inc. David Mott Vice President - Legal, R&D, and Regulatory 300 Executive Drive Edgewood, New York 11717
Re: K191103
Trade/Device Name: Parkell Desensitizer Gel Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: Class II Product Code: EJK, LBH Dated: October 24, 2019 Received: October 25, 2019
Dear David Mott:
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
1
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 (OS) 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 Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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) K191103
Device Name Parkell® Desensitizer Gel
Indications for Use (Describe)
Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:
- · treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion;
- · treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
- · treatment of tooth hypersensitivity associated with bleaching: and
- · treatment of prepared dentin for fillings and/or prosthetic restorations.
| 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
Image /page/3/Picture/0 description: The image shows the logo for Parkell Inc. The logo is in black and white and features the word "parkell" in a bold, sans-serif font. To the right of "parkell" and slightly below is the word "inc." in a smaller, italicized font. The overall design is simple and professional.
510(k) Summary – K191103
1. Submitter
Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 Phone: 631-389-1545 Fax: 631-389-1546 dmott@parkell.com
Contact Person: David Mott, Vice President - Legal & Regulatory Date of Initial Submission: April 24, 2019 Date of Submission of Final Revision: October 24, 2019
2. Device
| Device Proprietary Name: | Parkell® desensitizer |
|---|---|
| Common or Usual Name: | Tooth desensitizer |
| Classification Name: | Calcium hydroxide cavity liner |
| Regulation Number: | 21 CFR 872.3250 |
| Product Code: | EJK |
| Device Classification | II |
3. Primary Predicate
Teethmate Desensitizer, K131068, Kuraray Noritake Dental Inc.
4. Device Description
Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment sites. It is a gel which requires no mixing prior to use and which is applied to treatment sites using a standard applicator brush. Parkell® Desensitizer releases calcium and phosphate ions at the treatment site and stimulates hydroxyapatite formation on the surface of treated dentin and in dentinal tubules. In this manner, the Device hardens following application and forms a layer of mineral hydroxyapatite as well as hydroxyapatite plugs which occlude dentinal tubules, which results in the treatment of dental hypersensitivity.
Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.
4
Image /page/4/Picture/0 description: The image shows the logo for Parkell Inc. The logo is in black and white and features the word "parkell" in a bold, sans-serif font. To the right of "parkell" and slightly below is the word "inc." in a smaller, italicized font. The logo is simple and professional.
5. Indications for Use
Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:
- treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion;
- · treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
- treatment of tooth hypersensitivity associated with bleaching; and
- treatment of prepared dentin for fillings and/or prosthetic restorations.
6. Comparison of Technological Characteristics
Information provided in this 510(k) submission demonstrates that Parkell® Desensitizer Gel is substantially equivalent to the Primary Predicate (Teethmate Desensitizer, K131068), in terms of the intended use and technological characteristics.
Any differences between the Device and the Primary Predicate, for purposes of this 510(k) submission, are of a minor nature as is demonstrated in Table 5-A and throughout this submission. Thus, this submission demonstrates the substantial equivalence between Parkell® desensitizer and the Primary Predicate. A brief comparison of Parkell® Desensitizer Gel to the Primary Predicate is provided below:
| Property | Parkell® Desensitizer Gel
(Parkell, Inc.) | Primary Predicate
Teethmate Desensitizer (K131068, Kuraray Noritake Dental Inc.) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended uses | Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments: treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion; treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning; treatment of tooth hypersensitivity associated with bleaching; and treatment of prepared dentin for fillings and/or prosthetic restorations. | Teethmate Desensitizer is indicated for reduction of tooth hypersensitivity by the following treatments: treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion; treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning; treatment of tooth surface before and/or after bleaching; and treatment of prepared dentin for fillings and/or prosthetic restorations. |
| Classification Product Code | EJK | EJK |
| Regulation Number | 21 CFR 872.3250 | 21 CFR 872.3250 |
| Principle of operation | tooth desensitizer | tooth desensitizer |
| Material form | gel | powder/liquid |
Table 5-A:
5
Image /page/5/Picture/0 description: The image shows the logo for "parkell inc.". The word "parkell" is written in a bold, sans-serif font, with the letters closely spaced together. To the right of "parkell", the word "inc." is written in a smaller, italicized font. The logo is in black and white.
| | | Parkell® Desensitizer
Gel
(Parkell, Inc.) | Primary Predicate
Teethmate Desensitizer
(K131068, Kuraray) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------|
| Chemical composition | | water; calcium
phosphate-
based filler(s) | water; calcium
phosphate-
based filler(s) |
| Surface coverage of treated dentin | | yes | yes |
| Occludes dentinal tubules | | yes | yes |
| Microshear bond
strength to dentin of
resin-based bonding
agents following
pretreatment with
Device or Predicate
Device
(Pass/fail criteria of at
least about 15MPa) | Commercially-available
bonding agent #1
[self-etch mode] | ≥15MPa | ≥15MPa |
| | Commercially-available
bonding agent #1
[total-etch mode] | ≥15MPa | ≥15MPa |
| | Commercially-available
bonding agent #2
[self-etch mode] | ≥15MPa | ≥15MPa |
Table 5-A (continued):
As seen above, the differences between the subject and primary predicate devices are limited to materials of construction and material form. These technological differences do not raise issues with respect to substantial equivalence and are addressed by comparative performance data provided within this submission.
7. Biocompatibility and Bench Data
An evaluation of biocompatibility was conducted on Parkell® desensitizer in accordance, e.g., with ISO10993-1:2009, ISO10993-5:2009, ISO10993-10:2010, ISO10993-11:2017, ISO10993-12: 2012, and the FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016). The conclusion of the evaluation is that Parkell® Desensitizer Gel is biocompatible. In addition, an evaluation of the bioactivity of Parkell® desensitizer was performed through analysis of treated dental tissue and via tests performed in accordance with ISO23317:2014.
8. Clinical Performance Data
There was no clinical testing required to support the Device as the intended uses are equivalent to the Predicate Device. These types of devices have been on the market for many years with no reported adverse events. The non-clinical testing detailed in this submission supports the substantial equivalence of the Device.
9. Statement of Substantial Equivalence:
The information provided above supports that Parkell® Desensitizer Gel is substantially equivalent to the Primary Predicate. Although minor differences in design and technology exist between the subject and primary predicate devices, the testing supports that these differences do not raise questions as to the substantial equivalence between the devices. Therefore, it is concluded that Parkell® Desensitizer Gel is substantially equivalent to the Primary Predicate.