(147 days)
No
The device description focuses on chemical composition and bonding properties, with no mention of AI/ML terms or functionalities.
No.
The device is a dental primer used to enhance bonding between dental ceramics and resin-based materials, not to treat a disease or condition.
No
The device is described as a "dental primer" used to enhance bonding between dental ceramics and resin-based materials. Its purpose is to prepare surfaces for restorations and repairs, not to diagnose a condition or disease.
No
The device description clearly states it is a "two-part, self-cured dental primer" packaged in "two 5-milliliter bottles," indicating it is a chemical substance, not software.
Based on the provided information, the EAZY PRIMER™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- EAZY PRIMER™'s Intended Use: The intended use of EAZY PRIMER™ is to enhance bonding between dental materials (ceramics and resins) for restorations and repairs. It is applied to dental materials outside the human body before or during placement in the mouth.
- Device Description: The description confirms it's a dental primer used for surface treatments of restorations and repairs, not for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any analysis of human specimens, diagnostic purposes, or any of the typical characteristics associated with IVD devices.
Therefore, EAZY PRIMER™ is a dental material used in restorative dentistry, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EAZY PRIMER™ is indicated for use in enhancing bonding between dental ceramics (such as porcelain, lithium disilicate, zirconia or hybrid ceramics) and methacrylate resin-based materials. In addition, EAZY PRIMER™ is indicated for use in enhancing bonding between fractured dental ceramics and methacrylate resin-based materials during intra-oral repair of damaged restorations.
Product codes
KLE
Device Description
EAZY PRIMER™ is a two-part, self-cured dental primer which is used for enhancing the bond between dental ceramics (such as porcelain, lithium disilicate, zirconia, or hybrid ceramics) and methacrylate resin-based materials. The device is intended to be used to prepare surface treatments of restorations and repairs.
The device comprises both a silane-coupling agent and a phosphate-coupling agent which generate significant bond strengths between dental ceramic surfaces and methacrylate resin-based materials. As a consequence, like many FDA-cleared and legally-marketed dental primers, EAZY PRIMER™ enables users to enhance bonding between these surfaces without first using an etchant.
EAZY PRIMER™ is a two-part, self-cured dental primer. It is packaged in two 5-milliliter bottles ("bottle A" and "bottle B"), which will be mixed in a 1:1 ratio just prior to use.
All components of EAZY PRIMER™ are found in legally marketed predicate devices. The EAZY PRIMER™ is based upon industry standard monomer chemistry and has similar technological characteristics as other legally marketed dental primers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Shear Bond Strength tests were performed in accordance with ISO/TS 11405.
- Shear Bond Strength to Porcelain (>10MPa): >10MPa
- Shear Bond Strength to lithium disilicate (>10MPa): >10MPa
- Shear Bond Strength to zirconia (>10MPa): >10MPa
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the top of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2015
Parkell. Inc. Mr. David Mott VP, Regulatory Affairs 300 Executive Drive Edgewood, New York 11717
Re: K142848
Trade/Device Name: Eazy Primer™ Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: January 20, 2015 Received: January 22, 2015
Dear Mr. 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.
1
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 (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142848
Device Name EAZY PRIMER™
Indications for Use (Describe)
EAZY PRIMER™ is indicated for use in enhancing bonding between dental ceramics (such as porcelain, lithium disilicate, zirconia or hybrid ceramics) and methacrylate resin-based materials. In addition, EAZY PRIMER™ is indicated for use in enhancing bonding between fractured dental ceramics and methacrylate resin-based materials during intra-oral repair of damaged restorations.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
1. Submitter:
Parkell, Inc. 300 Executive Drive Edgewood, NY 11717
2. Contact:
David Mott, Esq. VP, Regulatory Affairs Tel: (631) 249-1134, ext. 145 Fax: (631) 249-1242
-
- Submission Date: September 29, 2014
বঁ Device Identification:
| Trade Name: | EAZY PRIMER™ |
|---|---|
| Common Name: | Dental Primer |
| Classification Name: | Resin Tooth Bonding Agent (21 CFR Section 872.3200) |
| Product Code: | KLE |
| Classification: | Class II |
5. Predicate and Reference Devices:
Predicate Device: Etch Free™ (510k no. 896719, filed as Primer-P Adhesive Agent) Reference Device: Z-PRIME Plus™ Primer (510K no. 091705, filed as Primer Plus)
Description of Applicant Device: 6.
EAZY PRIMER™ is a two-part, self-cured dental primer which is used for enhancing the bond between dental ceramics (such as porcelain, lithium disilicate, zirconia, or hybrid ceramics) and methacrylate resin-based materials. The device is intended to be used to prepare surface treatments of restorations and repairs.
The device comprises both a silane-coupling agent and a phosphate-coupling agent which generate significant bond strengths between dental ceramic surfaces and methacrylate resin-based materials. As a consequence, like many FDA-cleared and legally-marketed dental primers, EAZY PRIMER™ enables users to enhance bonding between these surfaces without first using an etchant.
7. Indications for Use:
EAZY PRIMER™ is indicated for use in enhancing bonding between dental ceramics (such as porcelain, lithium disilicate, zirconia or hybrid ceramics) and methacrylate resin-based materials. In addition, EAZY PRIMER™ is indicated for use in enhancing bonding between fractured dental ceramics and methacrylate resin-based materials during intra-oral repair of damaged restorations.
300 Executive Drive, Box 9004 Edgewood, New York 11717 USA Toll-Free: 800 248 7446 Phone: 631.249.1134 FAX: 631.249.1242 www.parkell.com
510(k) Summary
4
8. Technological Characteristics:
EAZY PRIMER™ is a two-part, self-cured dental primer. It is packaged in two 5-milliliter bottles ("bottle A" and "bottle B"), which will be mixed in a 1:1 ratio just prior to use.
All components of EAZY PRIMER™ are found in legally marketed predicate devices. The EAZY PRIMER™ is based upon industry standard monomer chemistry and has similar technological characteristics as other legally marketed dental primers.
9. Biocompatibility:
An evaluation of biocompatibility was conducted to determine the safety of EAZY PRIMER™ in accordance with ISO 10993-1: 2009, ISO 10993-5: 2009, ISO 10993-12: 2009, and the guidance document, "Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing". The biocompatibility evaluation included cytotoxicity testing in accordance with ISO 10993-5:2009. The conclusion of the evaluation is that EAZY PRIMER™ can be considered biocompatible.
10. Substantial Equivalence:
Information provided in this 510(k) submission demonstrates that EAZY PRIMER™ is substantially equivalent to the predicate device, Parkell Inc.'s existing Etch Free™ Primer (K896719) in terms of enhancing bonding to non-zirconia ceramics, as well as to the reference device (K091705) in terms of enhancing bonding to zirconia. The Shear Bond Strength tests were performed in accordance with ISO/TS 11405.
The minor differences between the device and the predicate device do not raise any new questions of safety or effectiveness. Thus, this submission demonstrates the safety and effectiveness of EAZY PRIMER™. A brief comparison of EAZY PRIMER™ to the predicate and reference devices is provided below:
| Property | EAZY PRIMER™
(Parkell, Inc.) | Predicate Device | Reference Device |
|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| (pass/fail criteria, if
applicable) | | (Etch Free™)
(Parkell, Inc.) | (Z-PRIME Plus®)
(Bisco, Inc.) |
| Intended use | Surface treatment to
enhance restorations
and repairs. | Surface treatment to
enhance restorations
and repairs. | Surface treatment to
enhance restorations
and repairs. |
| Self-Cure | Yes | Yes | Yes |
| Shelf Life | 3 years | 3 years | 2 years |
| Shear Bond
Strength to
Porcelain (>10MPa) | >10MPa | >10MPa | Not available |
| Shear Bond
Strength to lithium
disilicate (>10MPa) | >10MPa | >10MPa | Not available |
| Shear Bond
Strength to zirconia
(>10MPa) | >10MPa | Not available | >10MPa |