(353 days)
No
The device description and performance studies focus on the physical and chemical properties of a dental cement, with no mention of AI or ML.
No
The device is a self-adhesive resin cement used for the mechanical attachment of dental restorations, not for treating a disease or condition. Its function is primarily structural.
No
The device is a self-adhesive resin cement used for luting indirect restorations in dentistry. Its function is to bond dental restorations, not to diagnose medical conditions or diseases.
No
The device is a physical dental cement, not a software application. The description details its chemical composition, physical properties, and curing mechanisms, all of which are hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cementation of indirect dental restoratives (inlays, onlays, crowns, bridges, and posts). This is a therapeutic or restorative application, not a diagnostic one.
- Device Description: The description details a dental cement used for luting restorations. It focuses on physical properties and curing mechanisms, not on analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided clearly indicates a dental material used for bonding restorations within the mouth, which falls under the category of dental devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Parkell Self-Adhesive Cement is intenced for the cementation of induding ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Parkell Self-Adhesive Cement is a two-component, dual-cured, self-adhesive resin cement. It is designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia. The material also exhibits high bond strength and is radiopaque to allow visibility of excess in sub-gingival areas.
Parkell Self-Adhesive Cement will cure in 10 seconds with a dental curing light emitting blue light at 430 - 480 nm and a minimum intensity of 600 mW/cm². The product will self-cure in 3-4 minutes at mouth temperature.
Parkell Self-Adhesive Cement will be provided in 5 mL auto-mix syringes. The device comprises catalyst and base components, which are combined just prior to use via a static (1:1) mixing tip which is affixed to the dual chamber syringe.
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)
The following non-clinical studies were performed:
- Performance and Physical Properties
- Bond strength using different substrates. O
- O Compressive strength
- Water sorption and solubility O
- Depth of Cure O
- Barcol Hardness O
- O Flexural strength
- Radiopacity O
- Working Time/Setting Time at Room Temperature and oral temperature O
- O Calcium release
- Fluoride release O
- Phosphate release O
- Film Thickness O
- O Viscosity
- O Shelf Life
- Bioactivity O
- O Microleakage
- Ions Release and Recharge O
- Gap Closure O
An evaluation of biocompatibility was addressed for the safety of Parkell Self-Adhesive Cement in accordance with ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5: 2009, ISO 10993-6:2016, ISO 10993-10: 2010, ISO 10993-11:2017, ISO 10993-12: 2012, ISO 10993-33:2015 and the FDA's Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 4, 2020). The following table shows the tests that were conducted on the subject device.
| Cytotoxicity | ISO 10993-5 |
| Acute Systemic Toxicity Test | ISO 10993-11 |
| Primary oral (Buccal) irritation test | ISO 10993-10 |
| Genotoxicity Test | ISO 10993-3 |
| Sensitization Test | ISO 10993-10 |
| Implantation Test | ISO 10993-6 |
The conclusion of the evaluation is that Parkell Self-Adhesive Cement is substantially equivalent to the predicate device in terms of biocompatibility.
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.
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.
K190339, K172169, K161042, K151518, K190930, K182296, K020946, K141081, K111185, K102984, K143209
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
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January 20, 2022
Parkell, Inc La-Shaunda Joseph Regulatory/Compliance Manager 300 Executive Drive Edgewood, New York 11717
Re: K210259
Trade/Device Name: Parkell Self-Adhesive Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: January 4, 2022 Received: January 6, 2022
Dear La-Shaunda Joseph:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
For Michael E. Adjodha, M.ChE. 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
2
Indications for Use
510(k) Number (if known)
Device Name Parkell Self-Adhesive Cement
Indications for Use (Describe)
Parkell Self-Adhesive Cement is intenced for the cementation of induding ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.
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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510(k) Summary K210259
- Submitter
Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 Phone: 631-389-1560 ljoseph@parkell.com
Contact Person: La-Shaunda Joseph – Compliance and Regulatory Manager Date of Summary Preparation: January 19, 2022
2. Type of Submission: Traditional 510(k)
3. Device
| Device Proprietary Name: | Parkell Self-Adhesive Cement |
|---|---|
| Common or Usual Name: | Self-Adhesive Cement |
| Classification Name: | Dental Cement |
| Regulation Number: | 21 CFR 872.3275 |
| Product Code: | EMA |
| Device Classification | II |
4. Primary Predicate Device
Self-adhesive Cement (K073173, Dentsply International) (now marketed by Dentsply under the trade name "SmartCem2").
5. Device Description
Parkell Self-Adhesive Cement is a two-component, dual-cured, self-adhesive resin cement. It is designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia. The material also exhibits high bond strength and is radiopaque to allow visibility of excess in sub-gingival areas.
Parkell Self-Adhesive Cement will cure in 10 seconds with a dental curing light emitting blue light at 430 - 480 nm and a minimum intensity of 600 mW/cm². The product will self-cure in 3-4 minutes at mouth temperature.
Parkell Self-Adhesive Cement will be provided in 5 mL auto-mix syringes. The device comprises catalyst and base components, which are combined just prior to use via a static (1:1) mixing tip which is affixed to the dual chamber syringe.
Image /page/3/Picture/15 description: The image shows the logos for DirectaDentalGroup and some of its brands. The DirectaDentalGroup logo is in white text on a dark blue background. Below the DirectaDentalGroup logo are the logos for DIRECTA, topdental, ORSING, and parkell. The DIRECTA logo also includes the website address directadental.com.
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6. Indications for Use
Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.
7. Comparison of Technological Characteristics
The standards applicable to the subject device and to the comparison of technological characteristics referenced within the submission, include ISO 4049:2019 Dentistry - Polymer-based restorative materials, ISO 11405:2015 Dentistry - Testing of adhesion to tooth structure, ISO 16506:2017 Dentistry. Polymer-based luting materials containing adhesive components, ISO 13116:2014 Dentistry — Test method for determining radio-opacity of materials and ISO 23317:2014 Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials.
Information provided in these 510(k) submissions demonstrates that Parkell Self-Adhesive Cement is substantially equivalent to the Predicate Self-adhesive Cement (K073173) (now marketed by Dentsply under trade name, SmartCem2), in terms of similar intended use and technological characteristics (e.g. Compressive Strength, Depth of Cure, film thickness, flexural strength, radiopacity, water sorption and solubility), wherein Parkell Self-Adhesive Cement differs from the Predicate Device in the minor ways detailed in this Submission.
Parkell's Self-Adhesive Cement has expanded its intended use beyond the predicate device to include zirconia. Parkell has conducted the necessary tests to illustrate the efficacy of the Bonding Substrates to Zirconia.
Any differences between the Device and the Predicate Device, for purposes of this 510(k) submission, do not raise new questions of efficacy or safety. Thus, this submission demonstrates the substantial equivalence between Parkell Self-Adhesive Cement to the Predicate device. A brief comparison of Parkell Self-Adhesive Cement to the Primary Predicate is provided in Table 5-A below.
| Property | Parkell Device
Self-Adhesive Cement (Parkell,
Inc.) | Primary Predicate Device
510(k) no. K073173, SmartCem2,
filed as "Self-adhesive Cement" |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended uses | Parkell Self-Adhesive Cement is
intended for the cementation of
indirect restorations including
Ceramic, Zirconia, Composite
and Metal-based inlays, onlays,
Crowns, Bridges, and posts. | Self-adhesive Resin Cement is
intended for the cementation of
indirect restorations including
Ceramic, Composite and Metal-
based inlays, onlays, Crowns,
Bridges and posts. |
| Classification Product Code | EMA | EMA |
| Regulation Number | 872.3275 | 827.3275 |
| Principle of operation | Self-adhesive cementation of
indirect dental restorations | Self-adhesive cementation of
indirect dental restorations |
| Material form | Paste | Paste |
| Table 5-A: Comparison of Subject and Predicate Devices | ||
|---|---|---|
| Base/Catalyst Ratio | 1:1 | 1:1 |
| Polymerization Method | Dual-Cure | Dual-Cure |
| lons released | Fluoride | |
| Calcium | ||
| Phosphate | Fluoride | |
| Radiographic Appearance | Radiopaque | Radiopaque |
| Delivery System | Auto-mix syringe | Auto-mix syringe |
| Film Thickness (Microns) | ||
| Pass/Fail Criteria: ≤ 50 | ||
| microns | ≤ 50 microns | ≤ 50 microns |
| Working time (seconds) @ | ||
| 35 C Pass/Fail Criteria: ≤ 60 | ||
| seconds | ≤ 60 seconds | ≤ 60 seconds |
| Setting time (minutes) @ 35 | ||
| C Pass/Fail Criteria: ≤ 10 | ||
| minutes | ≤ 10 minutes | ≤ 10 minutes |
| Flexural strength LC (MPa) | ||
| Pass/Fail Criteria: ≥ 50 MPa | ≥ 50 MPa | ≥ 50 MPa |
| Flexural Strength SC (MPa) | ||
| Pass/Fail Criteria: ≥ 50 MPa | ≥ 50 MPa | ≥ 50 MPa |
| Compressive Strength LC | ||
| Pass/Fail Criteria: ≥ 200 MPa | ≥ 200 MPa | ≥ 200 MPa |
| Water Sorption (ug/mm³) | ||
| Pass/Fail Criteria: ≤ 40 | ||
| ug/mm³ | ≤ 40 ug/mm³ | ≤ 40 ug/mm³ |
| Water Solubility (ug/mm³) | ||
| Pass/Fail Criteria: ≤ 7.5 | ||
| u/mm³ | ≤ 7.5 u/mm³ | ≤ 7.5 u/mm³ |
| Radiopacity (% Al) Pass/Fail | ||
| Criteria: ≥ 100 %Al | ≥ 100 %Al | ≥ 100 %Al |
| Depth of Cure (mm) Pass/Fail | ||
| Criteria: ≥ 1mm | ≥ 1mm | ≥ 1mm |
| Diametral Tensile Strength | ||
| (MPa) Pass/Fail Criteria: ≥ 30 | ||
| MPa | ≥ 30 MPa | ≥ 30 MPa |
| Barcol Hardness after 20 | ||
| minutes @35c (MPa) | ||
| Pass/Fail Criteria: > 50 MPa | > 50 MPa | > 50 MPa |
| Barcol Hardness after 20 secs | ||
| Light Cure each surface | ||
| (MPa) Pass/Fail Criteria: > 60 | ||
| MPa | > 60 MPa | > 60 MPa |
| Film Thickness (Microns) | ||
| Pass/Fail Criteria: ≤ 50 | ||
| microns | ≤ 50 microns | ≤ 50 microns |
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Table 5-B: Comparison of Subject and Predicate Devices: Bond Strength to different Substrate
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| | | Parkell Device
Self-Adhesive
Cement
(Parkell, Inc.) | Predicate Device
510(k) no. K073173,
SmartCem2, filed as
"Self-Adhesive
Cement" |
|------------------------------------------------------|-----------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Substrate Pass/Fail Requirements | | Bond Strength (MPa) | Bond Strength (MPa) |
| Bonding Substrates to Composite Stumps | Treatment | | |
| Dentin LC (Pass/Fail Criteria: ≥ 6 MPa) | None | ≥ 6 MPa | ≥ 6 MPa |
| Dentin LC (Pass/Fail Criteria: ≥ 10 MPa) | PBA | ≥ 10 MPa | ≥ 10 MPa |
| Dentin SC (Pass/Fail Criteria: ≥ 3 MPa) | None | ≥ 3 MPa | ≥ 3 MPa |
| Enamel LC (Pass/Fail Criteria: ≥ 10 MPa) | None | ≥ 10 MPa | ≥ 10 MPa |
| Enamel LC (Pass/Fail Criteria: ≥ 10 MPa) | H3PO4 | ≥ 10 MPa | ≥ 10 MPa |
| Enamel SC (Pass/Fail Criteria: ≥ 3 MPa) | None | ≥ 3 MPa | ≥ 3 MPa |
| Lithium Disilicate LC (Pass/Fail Criteria: ≥ 5 MPa) | Silane | ≥ 5 MPa | ≥ 5 MPa |
| Lithium Disilicate LC (Pass/Fail Criteria: ≥ 10 MPa) | HF | ≥ 10 MPa | N/A |
| Zirconia LC (Pass/Fail Criteria: ≥ 10MPa) | SB | ≥ 10 MPa | ≥ 10 MPa |
| Zirconia LC (Pass/Fail Criteria: ≥ 10 MPa) | PBA | ≥ 10 MPa | N/A |
| Zirconia LC (Pass/Fail Criteria: ≥ 10MPa) | HF | ≥ 10 MPa | N/A |
| Zirconia SC (Pass/Fail Criteria: ≥ 5 MPa) | SB | ≥ 5MPa | ≥ 5MPa |
| Porcelain LC (Pass/Fail Criteria: ≥ 10MPa) | SB | ≥ 10 MPa | ≥ 10 MPa |
| Porcelain LC (Pass/Fail Criteria: ≥ 10 MPa) | Silane | ≥ 10 MPa | N/A |
| Porcelain LC (Pass/Fail Criteria: ≥ 10 MPa) | HF | ≥ 10 MPa | N/A |
| Porcelain SC (Pass/Fail Criteria: ≥ 5 MPa) | HF | ≥ 5 MPa | N/A |
| Palladium LC (Pass/Fail Criteria: ≥ 10 MPa) | SB | ≥10 MPa | ≥10 MPa |
| Titanium LC (Pass/Fail Criteria: ≥ 10 MPa) | SB | ≥10 MPa | ≥10 MPa |
| Titanium SC (Pass/Fail Criteria: ≥ 5 MPa) | SB | ≥ 5 MPa | ≥ 5 MPa |
| Cobalt LC (Pass/Fail Criteria: ≥ 10 MPa) | SB | ≥ 10MPa | ≥ 10MPa |
| Cobalt SC (Pass/Fail Criteria: ≥ 5 MPa) | SB | ≥ 5 MPa | ≥ 5 MPa |
As seen above, the differences between the subject and primary predicate devices are limited to minor differences 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.
8. Reference Devices
A table of the References devices used in this submission is shown below:
| Reference Device/Source | FDA 510(k) number |
|---|---|
| HelioSeal F (Ivoclar) | K190339 |
| Activa Pit and Fissure Sealant (Pulpdent) | K172169 |
| Clearfield Universal Bond Quick (Kuraray Dental Inc.) | K161042 |
| Brush&Bond 4-Meta Bonding System (Parkell Inc.) | K151518 |
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| Smartemp X1(Parkell Inc.) | K190930 |
|---|---|
| HyperFil-LV (Parkell Inc.) | K182296 |
| ESPE's Adper Easy Bond L-Pop dental adhesive (3M) | K020946 |
| ESPE's Filtek Bulk Fill Posterior (3M) | K141081 |
| RelyX luting plus automix (3M) | K111185 |
| Aura (SDI) | K102984 |
| Sonicfill 2 (Kerr) | K143209 |
9. Performance Testing
The following non-clinical studies were performed:
- Performance and Physical Properties
- Bond strength using different substrates. O
- O Compressive strength
- Water sorption and solubility O
- Depth of Cure O
- Barcol Hardness O
- O Flexural strength
- Radiopacity O
- Working Time/Setting Time at Room Temperature and oral temperature O
- O Calcium release
- Fluoride release O
- Phosphate release O
- Film Thickness O
- O Viscosity
- O Shelf Life
- Bioactivity O
- O Microleakage
- Ions Release and Recharge O
- Gap Closure O
10. Biocompatibility and Bench Data
An evaluation of biocompatibility was addressed for the safety of Parkell Self-Adhesive Cement in accordance with ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5: 2009, ISO 10933-6:2016, ISO 10993-10: 2010, ISO 10993-11:2017, ISO 10993-12: 2012, ISO 10993-33:2015 and the FDA's Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 4, 2020). The following table shows the tests that were conducted on the subject device.
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| Cytotoxicity | ISO 10993-5 |
|---|---|
| Acute Systemic Toxicity Test | ISO 10993-11 |
| Primary oral (Buccal) irritation test | ISO 10993-10 |
| Genotoxicity Test | ISO 10993-3 |
| Sensitization Test | ISO 10993-10 |
| Implantation Test | ISO 10993-6 |
The conclusion of the evaluation is that Parkell Self-Adhesive Cement is substantially equivalent to the predicate device in terms of biocompatibility.
11. 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.
12. Statement of Substantial Equivalence:
The information provided above supports that Parkell Self-Adhesive Cement 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 Self-Adhesive Cement is substantially equivalent to the Primary Predicate.