(125 days)
No
The device description and performance studies focus on the chemical composition and physical properties of a dental adhesive, with no mention of AI or ML technologies.
No.
The device is a dental adhesive used for bonding dental restorations and sealing tooth structures, not for treating a disease or condition therapeutically. Its functions (desensitization and sealing) are adjunctive to restorative procedures.
No
The device is a universal bonding agent for dental restorations and desensitization, not for diagnostic purposes.
No
The device description clearly indicates it is a chemical adhesive provided in a bottle with applicator brushes, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to direct application to tooth structures for bonding, sealing, and desensitization. These are clinical procedures performed directly on the patient.
- Device Description: The description details a bonding agent applied to dental surfaces. It does not mention any analysis of biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Anatomical Site: The anatomical sites are all parts of the tooth, which are treated directly.
- Performance Studies: The performance studies focus on shear bond strength, a measure of the physical adhesion of the material to tooth structure, not on diagnostic accuracy or analysis of biological markers.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers).
- Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia).
- Desensitization of dentin.
- Sealing of dentin, cementum or enamel.
Product codes
KLE
Device Description
The Parkell® Universal Adhesive is a single-component, one-bottle, light-cured universal bonding agent which utilizes proven 4-META and 10-MDP chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct and indirect dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.
The Parkell® Universal Adhesive will be provided in a single bottle, with standard applicator brushes for applying the adhesive to treatment surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, cementum, enamel, tooth structures, cavities, root surfaces
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
Shear bond strength tests were performed in accordance with ISO standards. The bond strengths achieved by the device were compared to that of the predicate device and were determined to be equivalent. Pass/fail criteria for initial shear bond strength was at least about 6MPa. The device met this criterion for Enamel, Dentin, Silver alloy, Cobalt-chrome alloy, Porcelain (following acid etching and sandblasting), Lithium disilicate (following sandblasting and HF acid etching), Zirconia (following sandblasting), and Composite Resin (self-cure and light-cure).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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November 21, 2017
Parkell. Inc. David Mott VP, Regulatory Affairs; General Counsel 300 Executive Drive Edgewood, New York 11717
Re: K172176
Trade/Device Name: Parkell Universal Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: October 23, 2017 Received: October 24, 2017
Dear Mr. 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. 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
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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 (OS) regulation (21 CFR Part 820); 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
for
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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Indications for Use
510(k) Number (if known) K172176
Device Name Parkell® Universal Adhesive
Indications for Use (Describe)
- Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers).
-
- Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia).
-
- Desensitization of dentin.
-
- Sealing of dentin, cementum or enamel.
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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K172176 510(k) Summary
-
- Submitter:
Parkell, Inc. 300 Executive Drive Edgewood, NY 11717
- Submitter:
-
- Contact:
David Mott, Esq. VP. Requlatory Affairs Tel: (631) 389-1545 Fax: (631) 249-1242 dmott@parkell.com
- Contact:
-
- Submission Date: October 23, 2017
-
Device Identification: 4.
| Trade Name: | Parkell® Universal Adhesive |
|---|---|
| Common Name: | Dental Bonding Agent |
| Classification Name: | Resin Tooth Bonding Agent (21 CFR Section 872.3200) |
| Product Code: | KLE |
| Classification: | Class II |
-
- Predicate Device:
Scotchbond® Universal Adhesive (K110302)/(3M ESPE)
- Predicate Device:
-
- Description of Proposed Device:
The Parkell® Universal Adhesive is a single-component, one-bottle, light-cured universal bonding agent which utilizes proven 4-META and 10-MDP chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct and indirect dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.
- Description of Proposed Device:
The Parkell® Universal Adhesive will be provided in a single bottle, with standard applicator brushes for applying the adhesive to treatment surfaces.
-
- Intended Use:
- Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, ﮯ resin core build-ups, compomers).
- ನ Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia).
- ನ Desensitization of dentin.
- Sealing of dentin, cementum or enamel. ব
As so described and as demonstrated in Table 5-A, the Device has the same intended uses as the Predicate Device (Scotchbond™ Universal Adhesive, 510K no. 110302, which has been marketed since about 2011), in that both devices are useful for direct and indirect dental restorations (e.g., inlays, onlays, crowns, bridges, varnishes and veneers), desensitizing
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teeth and root surfaces, and sealing tooth structures and cavities. Any differences in the descriptions of intended uses of the Device and Predicate Device, to the extent that they exist, are minor, not critical to the intended therapeutic uses of the Device, and do not affect the safety and/or effectiveness of the Device when used as labeled.
8. Technological Characteristics:
The proposed device, Parkell® Universal Adhesive, has the same intended use and contains similar chemical components to that of the predicate device (Scotchbond™ Universal Adhesive, K110302). The proposed device and its predicate both contain several of the same chemical components as well as identical functional categories of components, with the exception of a "filler" which is included only in the Predicate Device. The differences in chemical composition across the Device and Predicate Device are believed to have insubstantial effects on the intended use of the Device. This is evidenced by substantially similar performance by the proposed device and predicate devices in performance tests on a variety of dental substrates, as described in the device comparison table below.
Most importantly, all chemical components found in the proposed Device, but not within the Predicate Device, are commonly-used chemicals that are present in many FDA-cleared dental products which have long histories of safe use.
9. Biocompatibility:
An evaluation of biocompatibility was conducted to determine the safety of Parkell® Universal Adhesive in accordance with ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5: 2009, ISO 10993-10:2010, ISO 10993-12: 2012, ISO 10993-33:2015, and the Final 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® Universal Adhesive can be considered biocompatible.
10. Substantial Equivalence2:
Information provided in this 510(k) submission demonstrates that Parkell® Universal Adhesive is substantially equivalent to the Predicate Device, 3M ESPE's Scotchbond® Universal Adhesive (K110302) in terms of bond strength to dentin, enamel,metals, composite resins, and dental ceramics. The shear bond strength tests were performed in accordance with ISO standards. The bond strengths achieved by the Device were compared to that of the Predicate Device and were determined to be equivalent.
Any differences between the Device and the Predicate Device, for purposes of this 510(k) submission, do not raise new questions of safety or effectiveness. Thus, this submission demonstrates the safety and effectiveness of Parkell® Universal Adhesive. A brief comparison of Parkell® Universal Adhesive to the Predicate Device is provided below:
All statements contained herein are made solely for the purpose of demonstrating substantial equivalence as that term is defined in the context of SIO(k) submissions; the statements cannot be applied reliably or accurately in the context of U.S. patent or other intellectual property laws which involve vastly different legal standards and definitions (such as, e.g., within the context of 35 U.S.C. §§ 102, 103, 112, 271).
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Table 5-A:
| | Parkell® Universal Adhesive
(Parkell, Inc.) | Predicate Device
(Scotchbond® Universal Adhesive)
(3M) | Shear Bond Strength, Initial (MPa)
Pass/fail criteria: at least about 6MPa
("