Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and physical characteristics of dental composite materials, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No
The device is a dental composite material used for restorations and other dental procedures, not a therapeutic device.

Diagnostic

No
The device is described as a composite material for dental restorations and core build-ups. Its intended uses and performance studies focus on physical and biological properties relevant to restorative materials, not on diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "light-cured, radiopaque, universal hybrid composite" and a "mixture of organic resin and inorganic filler," indicating it is a physical material, not software. The performance studies also focus on material properties.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended uses listed are for direct dental restorations, core build-ups, splinting, and other dental procedures performed directly on the patient's teeth. These are therapeutic and restorative procedures, not diagnostic tests performed on samples taken from the body.
Device Description: The description details the composition and properties of dental composite materials used for filling cavities and restoring teeth. This aligns with a dental restorative material, not a diagnostic device.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
Anatomical Site: The anatomical site is the anterior and posterior regions of the teeth, which are the sites of the dental procedures, not where diagnostic samples would typically be collected or analyzed.

In summary, this device is a dental restorative material used for treating dental issues, not for diagnosing them.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe)

· Direct anterior & posterior restorations
· Core Build Ups
· Splinting

IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza)

· Class III, V & smaller Class IV restorations
· Base/liner in Class I & Class II restorations
· Repair resin, porcelain & acrylic temporary materials
· Pit & fissure sealant
· Undercut blockout
· Restoration of minimally invasive cavity preparations

Product codes (comma separated list FDA assigned to the subject device)

EBF, EJK, EBC

Device Description

IMICRYL Composite Materials include the brands Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. IMICRYL Composite Materials; It is a light-cured, radiopaque, universal hybrid composite suitable for use in the anterior and posterior regions. It is packaged in a black syringe to protect it from light.

IMICRYL Flow Composite materials include the Nova Compo HF, Othocompo, Luxera and Maritza brands. IMICRYL Flow Composite materials; It is a light-cured hybrid radiopaque composite with a fluid consistency. Composite materials are a mixture of organic resin and inorganic filler. The resin matrix contains Bis-GMA and TEGDMA is added to decrease the viscosity.

There are differences in viscosity between composites and flowable composites.

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)

NON-CLINICAL BENCH TESTING:
IMICRYL COMPOSITE AND PROFIL COMPOSITE TEST RESULTS

Compressive Strength: IMICRYL Composite, Materials (Lot No: 17125) 420 MPa; ProFil Composite 440 MPa
Flexural Strength: IMICRYL Composite, Materials (Lot No: 17125) 167 MPa; ProFil Composite 187 MPa
Surface Hardness: IMICRYL Composite, Materials (Lot No: 17125) 265 MHV; ProFil Composite 285 MHV
Water Sorption: IMICRYL Composite, Materials (Lot No: 17125) 16.8 microg/mmcubed; ProFil Composite 18.4 microg/mmcubed
Water Solubility: IMICRYL Composite, Materials (Lot No: 17125) 0.3 microg/mmcubed; ProFil Composite 0.5 microg/mmcubed
Polymerization Shrinkage: IMICRYL Composite (Lot No: 17125) 1.45 %; ProFil Composite 1.57 %
Diametral Tensile Strength: IMICRYL Composite (Lot No: 17125) 31 MPa; ProFil Composite 30 MPa
Flexural Modulus: IMICRYL Composite (Lot No: 17125) 126.87 MPa; ProFil Composite 130 MPa
Radiopacity: IMICRYL Composite (Lot No: 17125) 6 mm of Al; ProFil Composite 6.87 mm of Al
Depth of Cure: IMICRYL Composite (Lot No: 17125) 2.5 mm; ProFil Composite 2.8 mm
Elastic Modulus: IMICRYL Composite (Lot No: 17125) 16.8 GPa; ProFil Composite 17.1 GPa
Intensity for Curing: IMICRYL Composite (Lot No: 17125) 1200 mW/cm2 – 10 sec, 500 mW/cm2 – 20 sec; ProFil Composite 1200 mW/cm2 – 10 sec, 500 mW/cm2 – 20 sec
Wavelength for Curing: IMICRYL Composite (Lot No: 17125) 470 nm; ProFil Composite 470 nm
Filler Particle Size Distribution: IMICRYL Composite (Lot No: 17125) 0.7 microm; ProFil Composite 0.7 microm
Working Time: IMICRYL Composite (Lot No: 17125) 38 second; ProFil Composite 35 second
Setting Time: IMICRYL Composite (Lot No: 17125) 4 minute; ProFil Composite 4 minute 10 second
Curing Time: IMICRYL Composite (Lot No: 17125) 20 second; ProFil Composite 20 second

IMICRYL COMPOSITE FLOW AND PROFIL COMPOSITE FLOW TEST RESULTS

Compressive Strength: IMICRYL Composite Flow (Lot No: 17126) 380 MPa; ProFil Composite Flow 370 MPa
Flexural Strength: IMICRYL Composite Flow (Lot No: 17126) 165 MPa; ProFil Composite Flow 160 MPa
Surface Hardness: IMICRYL Composite Flow (Lot No: 17126) 265 MHV; ProFil Composite Flow 285 MHV
Water Sorption: IMICRYL Composite Flow (Lot No: 17126) 16.8 microg/mmcubed; ProFil Composite Flow 18.4 microg/mmcubed
Water Solubility: IMICRYL Composite Flow (Lot No: 17126) 0.3 microg/mmcubed; ProFil Composite Flow 0.5 microg/mmcubed
Polymerization Shrinkage: IMICRYL Composite Flow (Lot No: 17126) 2.2 %; ProFil Composite Flow 2 %
Diametral Tensile Strength: IMICRYL Composite Flow (Lot No: 17126) 68 MPa; ProFil Composite Flow 65 MPa
Flexural Modulus: IMICRYL Composite Flow (Lot No: 17126) 126.87 MPa; ProFil Composite Flow 130 MPa
Radiopacity: IMICRYL Composite Flow (Lot No: 17126) 3.5 mm of Al; ProFil Composite Flow 3 mm of Al
Depth of Cure: IMICRYL Composite Flow (Lot No: 17126) 3.8 mm; ProFil Composite Flow 3 mm
Elastic Modulus: IMICRYL Composite Flow (Lot No: 17126) 16.8 GPa; ProFil Composite Flow 17.1 GPa
Intensity for Curing: IMICRYL Composite Flow (Lot No: 17126) 1200 mW/cmsquared - 10 sec, 500 mW/cmsquared – 20 sec; ProFil Composite Flow 1200 mW/cmsquared - 10 sec, 500 mW/cmsquared – 20 sec
Wavelength for Curing: IMICRYL Composite Flow (Lot No: 17126) 470 nm; ProFil Composite Flow 470 nm
Filler Particle Size Distribution: IMICRYL Composite Flow (Lot No: 17126) 0.7 microm; ProFil Composite Flow 0.7 microm
Working Time: IMICRYL Composite Flow (Lot No: 17126) 38 second; ProFil Composite Flow 35 second
Setting Time: IMICRYL Composite Flow (Lot No: 17126) 4 minute; ProFil Composite Flow 4 minute 10 second
Curing Time: IMICRYL Composite Flow (Lot No: 17126) 20 second; ProFil Composite Flow 20 second

NON-CLINICAL PERFORMANCE TESTING:
Biocompatibility Testing:

Cytotoxicity: The device has not cytotoxic potential.
Sensitization: The device does not cause hypersensitive skin reaction.
Intradermal Reactivity: The device does not cause intradermal irritation.
Acute Systemic Toxicity: The device has no acute systemic toxic effect.
Subacute Systemic Toxicity (non-polar): The device does not have a subacute systemic toxic effect.
Subacute Systemic Toxicity (polar): The device does not have a subacute systemic toxic effect.
Genotoxicity (OECD 471): The device has no mutagenic potential.
Genotoxicity (OECD 487): The device has no genotoxic potential.
Implantation: Irritant effect was not found.

Physical Testing:
In-vitro bench tests were performed on the IMICRYL Composite Flow Materials according to the requirements in ISO 4049 Dentistry -- Polymer-based restorative materials and ISO 17304 Dentistry — Polymerization Shrinkage: Method For Determination of Polymerization Shrinkage of Polymer-Based Restorative Materials.

Bench tests included in support of the substantial equivalence of IMICRYL Composite, Composite Flow are:

Compressive Strength .
. Flexural Strength
Surface Hardness ●
. Water Sorption and Solubility
. Polymerization Shrinkage
Diametral Tensile Strength
Flexural Modulus ●
. Radiopacity
. Depth of Cure

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.

K103190

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

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.

Summary

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 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.

August 9, 2022

Imicryl Dis Malzemeleri Sanayi Ve Ticaret As Husamettin Sonmez General Manager Fetih Mahallesi Mahir Sokak No:5/201 Karatay Konya. 42030 Turkey

Re: K220077

Trade/Device Name: IMICRYL Composite, Composite Flow Materials Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC, EJK Dated: July 5, 2022 Received: July 11, 2022

Dear Husamettin Sonmez:

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) K220077

Device Name

IMICRYL Composite, Composite Flow Materials

Indications for Use (Describe)

IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe)

· Direct anterior & posterior restorations
· Core Build Ups
· Splinting

IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza)

· Class III, V & smaller Class IV restorations
· Base/liner in Class I & Class II restorations
· Repair resin, porcelain & acrylic temporary materials
· Pit & fissure sealant
· Undercut blockout
· Restoration of minimally invasive cavity preparations

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

Image /page/3/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem on the left with the letters "IMI" inside, and the word "IMICRYL" in large, bold letters to the right. Below the logo is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş."

K220077

510(k) Summary

IMICRYL Composite. Composite Flow Materials

The IMICRYL family of composite materials: includes the brand names Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. The IMICRYL family of composite flow materials: includes the brand names Nova Compo HF, Othocompo, Luxera, Maritza

Date of Summary Preparation: November 30, 2021

Type of Submission: Traditional 510(k)

SUBMITTER INFORMATION:

Company Name: IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.

Company Address: Fetih Mahallesi Mahir Sokak No: 5/201 Zip Code:42030 Karatay/Konya/TURKEY

Phone Number: 0090 444 71 30

Fax Number: 0090 332 355 76 19

Contact Person: Husamettin SONMEZ

Phone: 0090 444 71 30 ext: 120

E-mail: kaliteguvence@imicryl.com

Secondary Contact Person: Muhammed Hulusi SONMEZ

Phone: 0090 444 71 30 ext: 123

E-mail: hsonmez@imicryl.com.tr

DEVICE INFORMATION:

Trade Name: IMICRYL Composite, Composite Flow Materials Common Name: Composite Materials Primary Product Code: EBF Secondary Product Code: EJK, EBC Classification: Class II Classification Name: Tooth shade resin, material 21 CFR 872.3690 Regulation Number: 21 CFR 872.3690

Review Panel: Dental

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Image /page/4/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem with the letters "IMI" inside, followed by the word "IMICRYL" in a bold, sans-serif font. Below the word is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in a smaller, sans-serif font.

PREDICATE DEVICES:

IMICRYL Composite, Composite Flow Materials is substantially equivalent to the following marketed product:

COMPANY	DEVICE	510(k) NUMBER	PRODUCT CODE
Silmet Ltd.	ProFil Composites (ProFil,
ProFil Flow)	K103190	EBF

INDICATION FOR USE:

IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe)

. Direct anterior & posterior restorations
Core Build Ups
Splinting

IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza)

. Class III, V & smaller Class IV restorations
. Base/liner in Class I & Class II restorations
Repair resin, porcelain & acrylic temporary materials
. Pit & fissure sealant
. Undercut blockout
Restoration of minimally invasive cavity preparations

DEVICE DESCRIPTION:

IMICRYL Composite Materials include the brands Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. IMICRYL Composite Materials; It is a light-cured, radiopaque, universal hybrid composite suitable for use in the anterior and posterior regions. It is packaged in a black syringe to protect it from light.

IMICRYL Flow Composite materials include the Nova Compo HF, Othocompo, Luxera and Maritza brands. IMICRYL Flow Composite materials; It is a light-cured hybrid radiopaque composite with a fluid consistency. Composite materials are a mixture of organic resin and inorganic filler. The resin matrix contains Bis-GMA and TEGDMA is added to decrease the viscosity.

There are differences in viscosity between composites and flowable composites.

SUBSTANTIAL EQUIVALENCE:

The applicant device has the same intended use as the 510(k) cleared predicates listed above.

Table 1 below shows a comparison of IMICRYL Composite, Composite Flow Materials and the predicates.

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Image /page/5/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of the word "IMICRYL" in large, bold, blue letters, with a registered trademark symbol next to it. To the left of the word is a blue oval shape with the letters "IMI" inside. Below the word "IMICRYL" is the phrase "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters.

Table 1: Comparison with Predicate Device

| DESCRIPTIVE
INFORMATION | NEW DEVICE
IMICRYL Composite, Composite Flow Materials (K220077) | PREDICATE DEVICE
ProFil Composites (ProFil, ProFil Flow), [K103190] | REMARK |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| INDICATIONS FOR USE | | | |
| | IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova
Compo HS, Balo, Swarpe) | ProFil | The indications for use of the new
device and the equivalent device
are the same. |
| | Direct anterior & posterior restorations Core Build Ups Splinting | Direct anterior & posterior restorations Core Build Ups Splinting | |
| | IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo,
Luxera, Maritza) | ProFil Flow | |
| | Class III, V & smaller Class IV restorations Base/liner in Class I & Class II restorations Repair resin, porcelain & acrylic temporary materials Pit & fissure sealant Undercut blockout Restoration of minimally invasive cavity preparations | Class III, V & smaller Class IV restorations Base/liner in Class I & Class II restorations Repair resin, porcelain & acrylic temporary materials Pit & fissure sealant Undercut blockout Restoration of minimally invasive cavity preparations | |

Similarities

· IMICRYL Composite, Composite Flow Materials it is exactly similar to the equivalent device in terms of composition ind physical properties.
We believe that the prior use of these components in leally marketed devices and the performance data and results support the safety and effectiveness of IMICRYL Composite Flow Materials for the intended use.

Differences

There is no difference.

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Image /page/6/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem with the letters "IMI" inside, followed by the word "IMICRYL" in a bold, sans-serif font. Below the word is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in a smaller font.

TECHNOLOGICAL PROPERTIES

| Technological property | NEW DEVICE
IMICRYL Composite, Composite
Flow Materials (K220077) | PREDICATE DEVICE
ProFil Composites (ProFil,
ProFil Flow), [K103190] |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Camphorquinone/amine
photoinitiator system | ✓ | ✓ |
| Methacrylate-based resin matrix | ✓ | ✓ |
| Silane treated fillers | ✓ | ✓ |
| Bonded with a permanent dental
adhesive | ✓ | ✓ |
| When irradiated by light, the
methacrylate functionalities of
the resins and surface treated
fillers undergo, in conjunction
with the photoinitiator system, I
light induced polymerization to
form a hard composite that is
bonded to the tooth structure
with a permanent dental
adhesive | ✓ | ✓ |

NON-CLINICAL BENCH TESTING:

IMICRYL COMPOSITE AND PROFIL COMPOSITE TEST RESULTS

| Sample Name | Compressive
Strength
(MPa) | Flexural
Strength
(MPa) | Surface
Hardness
(MHV) | Water
Sorption
(µg/mm³) | Water
Solubility
(µg/mm³) |
|-------------------------------------------------------|----------------------------------|-------------------------------|------------------------------|-------------------------------|---------------------------------|
| IMICRYL
Composite,
Materials
(Lot No: 17125) | 420 MPa | 167 MPa | 265 MHV | 16.8 µg/mm³ | 0.3 µg/mm³ |
| ProFil
Composite | 440 MPa | 187 MPa | 285 MHV | 18.4 µg/mm³ | 0.5 µg/mm³ |

| Sample Name | Polymerization
Shrinkage | Diametral
Tensile
Strength | Flexural
Modulus | Radiopacity | Depth of
Cure |
|--------------------------------------------|-----------------------------|----------------------------------|---------------------|---------------|------------------|
| IMICRYL
Composite
(Lot No:
17125) | 1.45 % | 31 MPa | 126.87 MPa | 6 mm of Al | 2.5 mm |
| ProFil
Composite | 1.57 % | 30 MPa | 130 MPa | 6.87 mm of Al | 2.8 mm |

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Image /page/7/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem with the letters "IMI" inside a stylized shape, followed by the word "IMICRYL" in bold, blue letters. Below the word "IMICRYL" is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş."

| Sample Name | Elastic
Modulus | Intensity for
Curing | Wavelength
for Curing | Filler Particle
Size
Distribution |
|-----------------------------------------|--------------------|-----------------------------------------------------|--------------------------|-----------------------------------------|
| IMICRYL
Composite
(Lot No: 17125) | 16.8 GPa | 1200 mW/cm2 –
10 sec.
500 mW/cm2 –
20 sec. | 470 nm | 0.7 μm |
| ProFil
Composite | 17.1 GPa | 1200 mW/cm2 –
10 sec.
500 mW/cm2 –
20 sec. | 470 nm | 0.7 μm |

Sample Name	Working Time	Setting Time	Curing Time
IMICRYL Composite
(Lot No: 17125)	38 second	4 minute	20 second
ProFil Composite	35 second	4 minute 10
second	20 second

IMICRYL COMPOSITE FLOW AND PROFIL COMPOSITE FLOW TEST RESULTS

| Sample Name | Compressive
Strength
(MPa) | Flexural
Strength
(MPa) | Surface
Hardness
(MHV) | Water
Sorption
(µg/mm³) | Water
Solubility
(µg/mm³) | Sample Name | Polymerization
Shrinkage | Diametral
Tensile
Strength | Flexural
Modulus | Radiopacity | Depth of
Cure |
|----------------------------------------------------|----------------------------------|-------------------------------|------------------------------|-------------------------------|---------------------------------|----------------------------------------------------|-----------------------------|----------------------------------|---------------------|--------------|------------------|
| IMICRYL
Composite
Flow
(Lot No:
17126) | 380 MPa | 165 MPa | 265 MHV | 16.8 µg/mm³ | 0.3 µg/mm³ | IMICRYL
Composite
Flow
(Lot No:
17126) | 2.2 % | 68 MPa | 126.87 MPa | 3.5 mm of Al | 3.8 mm |
| ProFil
Composite
Flow | 370 MPa | 160 MPa | 285 MHV | 18.4 µg/mm³ | 0.5 µg/mm³ | ProFil
Composite
Flow | 2 % | 65 MPa | 130 MPa | 3 mm of Al | 3 mm |

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Image /page/8/Picture/0 description: The image is a logo for IMICRYL. The logo consists of a blue circle with a white oval inside, containing the letters "IMI" in blue. To the right of the circle is the word "IMICRYL" in large, blue letters, with a registered trademark symbol above the "L". Below the circle and the word "IMICRYL" is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters.

| Sample Name | Elastic
Modulus | Intensity for
Curing | Wavelength
for Curing | Filler Particle
Size
Distribution | Sample Name | Working Time | Setting Time | Curing Time |
|----------------------------------------------|--------------------|---------------------------------------------------|--------------------------|-----------------------------------------|-------------------------------------------|--------------|-----------------------|-------------|
| IMICRYL
Composite Flow
(Lot No: 17126) | 16.8 GPa | 1200 mW/cm² -
10 sec
500 mW/cm² –
20 sec | 470 nm | 0.7 μm | IMICRYL Composite
Flow (Lot No: 17126) | 38 second | 4 minute | 20 second |
| ProFil
Composite Flow | 17.1 GPa | 1200 mW/cm² -
10 sec
500 mW/cm² –
20 sec | 470 nm | 0.7 μm | ProFil Composite Flow | 35 second | 4 minute 10
second | 20 second |

NON-CLINICAL PERFORMANCE TESTING:

Biocompatibility Testing:

Cytotoxicity	The device has not cytotoxic potential.
Sensitization	The device does not cause hypersensitive skin reaction.
Intradermal Reactivity	The device does not cause intradermal irritation.
Acute Systemic Toxicity	The device has no acute systemic toxic effect.
Subacute Systemic Toxicity
(non-polar)	The device does not have a subacute systemic toxic effect.
Subacute Systemic Toxicity
(polar)	The device does not have a subacute systemic toxic effect.
Genotoxicity (OECD 471)	The device has no mutagenic potential.
Genotoxicity (OECD 487)	The device has no genotoxic potential.
Implantation	Irritant effect was not found.

Physical Testing:

In-vitro bench tests were performed on the IMICRYL Composite Flow Materials according to the requirements in ISO 4049 Dentistry -- Polymer-based restorative materials and ISO 17304 Dentistry — Polymerization Shrinkage: Method For Determination of Polymerization Shrinkage of Polymer-Based Restorative Materials.

Bench tests included in support of the substantial equivalence of IMICRYL Composite, Composite Flow are:

Compressive Strength .
. Flexural Strength
Surface Hardness ●
. Water Sorption and Solubility
. Polymerization Shrinkage
Diametral Tensile Strength
Flexural Modulus ●
. Radiopacity
. Depth of Cure

9

Image /page/9/Picture/0 description: The image is a logo for IMICRYL. The logo consists of the word "IMICRYL" in large, bold, blue letters, with a registered trademark symbol next to it. To the left of the word is a blue circle containing the letters "IMI" in white. Below the word "IMICRYL" is the phrase "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters.

CONCLUSION

In accordance with 21 C.F.R part 807 and FDA' s "Guidance for the preparation of Premarket Notifications for Dental Composites" and based on the information provided in this premarket notification, IMICRYL AS. concludes that IMICRYL Composite, Composite Flow Materials are safe and effective and substantially equivalent to the predicate devices described herein.