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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for dental composite materials. It is not about an AI/ML-enabled medical device, diagnostic tool, or a study that assesses human performance with or without AI assistance. Therefore, it does not include information on acceptance criteria, expert adjudication, MRMC studies, standalone AI performance, or ground truth establishment in the context of AI/ML.

The document focuses on demonstrating the substantial equivalence of the IMICRYL Composite, Composite Flow Materials to a legally marketed predicate device (ProFil Composites). The acceptance criteria are implicit in the comparison tables, showing that the new device's performance characteristics are comparable to or meet the standards set by the predicate device and relevant ISO standards.

Here's an attempt to answer the questions based on the provided document, acknowledging its limitations regarding AI/ML:

1. A table of acceptance criteria and the reported device performance

The document compares the new device (IMICRYL Composite, Composite Flow Materials) against a predicate device (ProFil Composites) using various technological and non-clinical bench testing parameters. The "acceptance criteria" can be inferred as achieving values comparable to the predicate device, as the submission aims to prove substantial equivalence.

IMICRYL Composite Performance vs. Predicate Device (ProFil Composite)

Metric	IMICRYL Composite (Lot No: 17125)	ProFil Composite (Predicate)	Implied Acceptance Criteria (Comparable to Predicate)
Compressive Strength	420 MPa	440 MPa	Commensurate with ProFil (e.g., within a reasonable range of 440 MPa)
Flexural Strength	167 MPa	187 MPa	Commensurate with ProFil (e.g., within a reasonable range of 187 MPa)
Surface Hardness	265 MHV	285 MHV	Commensurate with ProFil (e.g., within a reasonable range of 285 MHV)
Water Sorption	16.8 µg/mm³	18.4 µg/mm³	Lower or comparable to ProFil
Water Solubility	0.3 µg/mm³	0.5 µg/mm³	Lower or comparable to ProFil
Polymerization Shrinkage	1.45 %	1.57 %	Lower or comparable to ProFil
Diametral Tensile Strength	31 MPa	30 MPa	Comparable to or higher than ProFil
Flexural Modulus	126.87 MPa	130 MPa	Commensurate with ProFil (e.g., within a reasonable range of 130 MPa)
Radiopacity	6 mm of Al	6.87 mm of Al	Commensurate with ProFil
Depth of Cure	2.5 mm	2.8 mm	Commensurate with ProFil
Elastic Modulus	16.8 GPa	17.1 GPa	Commensurate with ProFil
Intensity for Curing	1200 mW/cm2 – 10 sec, 500 mW/cm2 – 20 sec	1200 mW/cm2 – 10 sec, 500 mW/cm2 – 20 sec	Same as ProFil
Wavelength for Curing	470 nm	470 nm	Same as ProFil
Filler Particle Size Dist.	0.7 μm	0.7 μm	Same as ProFil
Working Time	38 second	35 second	Comparable to ProFil
Setting Time	4 minute	4 minute 10 second	Comparable to ProFil
Curing Time	20 second	20 second	Same as ProFil

IMICRYL Composite Flow Performance vs. Predicate Device (ProFil Composite Flow)

Metric	IMICRYL Composite Flow (Lot No: 17126)	ProFil Composite Flow (Predicate)	Implied Acceptance Criteria (Comparable to Predicate)
Compressive Strength	380 MPa	370 MPa	Comparable to or higher than ProFil Flow
Flexural Strength	165 MPa	160 MPa	Comparable to or higher than ProFil Flow
Surface Hardness	265 MHV	285 MHV	Commensurate with ProFil Flow
Water Sorption	16.8 µg/mm³	18.4 µg/mm³	Lower or comparable to ProFil Flow
Water Solubility	0.3 µg/mm³	0.5 µg/mm³	Lower or comparable to ProFil Flow
Polymerization Shrinkage	2.2 %	2 %	Comparable to ProFil Flow
Diametral Tensile Strength	68 MPa	65 MPa	Comparable to or higher than ProFil Flow
Flexural Modulus	126.87 MPa	130 MPa	Commensurate with ProFil Flow
Radiopacity	3.5 mm of Al	3 mm of Al	Comparable to or higher than ProFil Flow
Depth of Cure	3.8 mm	3 mm	Comparable to or higher than ProFil Flow
Elastic Modulus	16.8 GPa	17.1 GPa	Commensurate with ProFil Flow
Intensity for Curing	1200 mW/cm² - 10 sec, 500 mW/cm² – 20 sec	1200 mW/cm² - 10 sec, 500 mW/cm² – 20 sec	Same as ProFil Flow
Wavelength for Curing	470 nm	470 nm	Same as ProFil Flow
Filler Particle Size Dist.	0.7 μm	0.7 μm	Same as ProFil Flow
Working Time	38 second	35 second	Comparable to ProFil Flow
Setting Time	4 minute	4 minute 10 second	Comparable to ProFil Flow
Curing Time	20 second	20 second	Same as ProFil Flow

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document refers to "bench tests" and does not specify sample sizes (e.g., number of specimens for each test like compressive strength). It implies in-house testing was performed for the IMICRYL products to generate the reported data. The country of origin for the data generation (testing) would likely be Turkey, where the manufacturer (IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.) is located. These are laboratory-based, non-clinical tests, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable to this type of device submission. There were no human experts establishing "ground truth" as it relates to image interpretation or clinical outcomes. The "ground truth" for material properties is established by adherence to recognized international standards (e.g., ISO 4049, ISO 17304) and laboratory testing methodologies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical bench testing submission, not an clinical study requiring expert adjudication of data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for a dental restorative material, not an AI-enabled diagnostic device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the physical, mechanical, and biological properties of the material, measured through standardized non-clinical bench tests (e.g., compressive strength, flexural strength, biocompatibility tests). These measurements are quantifiable and objective, not dependent on expert consensus, pathology, or outcomes data in the way medical imaging AI devices are. The "truth" is established by laboratory measurements according to ISO standards.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no training set and thus no ground truth established for one.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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

{4}------------------------------------------------

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:

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.

{5}------------------------------------------------

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

DESCRIPTIVEINFORMATION	NEW DEVICEIMICRYL Composite, Composite Flow Materials (K220077)	PREDICATE DEVICEProFil Composites (ProFil, ProFil Flow), [K103190]	REMARK
INDICATIONS FOR USE
	IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, NovaCompo HS, Balo, Swarpe)	ProFil	The indications for use of the newdevice and the equivalent deviceare 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.

{6}------------------------------------------------

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 DEVICEIMICRYL Composite, CompositeFlow Materials (K220077)	PREDICATE DEVICEProFil Composites (ProFil,ProFil Flow), [K103190]
Camphorquinone/aminephotoinitiator system	✓	✓
Methacrylate-based resin matrix	✓	✓
Silane treated fillers	✓	✓
Bonded with a permanent dentaladhesive	✓	✓
When irradiated by light, themethacrylate functionalities ofthe resins and surface treatedfillers undergo, in conjunctionwith the photoinitiator system, Ilight induced polymerization toform a hard composite that isbonded to the tooth structurewith a permanent dentaladhesive	✓	✓

NON-CLINICAL BENCH TESTING:

IMICRYL COMPOSITE AND PROFIL COMPOSITE TEST RESULTS

Sample Name	CompressiveStrength(MPa)	FlexuralStrength(MPa)	SurfaceHardness(MHV)	WaterSorption(µg/mm³)	WaterSolubility(µg/mm³)
IMICRYLComposite,Materials(Lot No: 17125)	420 MPa	167 MPa	265 MHV	16.8 µg/mm³	0.3 µg/mm³
ProFilComposite	440 MPa	187 MPa	285 MHV	18.4 µg/mm³	0.5 µg/mm³

Sample Name	PolymerizationShrinkage	DiametralTensileStrength	FlexuralModulus	Radiopacity	Depth ofCure
IMICRYLComposite(Lot No:17125)	1.45 %	31 MPa	126.87 MPa	6 mm of Al	2.5 mm
ProFilComposite	1.57 %	30 MPa	130 MPa	6.87 mm of Al	2.8 mm

{7}------------------------------------------------

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	ElasticModulus	Intensity forCuring	Wavelengthfor Curing	Filler ParticleSizeDistribution
IMICRYLComposite(Lot No: 17125)	16.8 GPa	1200 mW/cm2 –10 sec.500 mW/cm2 –20 sec.	470 nm	0.7 μm
ProFilComposite	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 10second	20 second

IMICRYL COMPOSITE FLOW AND PROFIL COMPOSITE FLOW TEST RESULTS

Sample Name	CompressiveStrength(MPa)	FlexuralStrength(MPa)	SurfaceHardness(MHV)	WaterSorption(µg/mm³)	WaterSolubility(µg/mm³)	Sample Name	PolymerizationShrinkage	DiametralTensileStrength	FlexuralModulus	Radiopacity	Depth ofCure
IMICRYLCompositeFlow(Lot No:17126)	380 MPa	165 MPa	265 MHV	16.8 µg/mm³	0.3 µg/mm³	IMICRYLCompositeFlow(Lot No:17126)	2.2 %	68 MPa	126.87 MPa	3.5 mm of Al	3.8 mm
ProFilCompositeFlow	370 MPa	160 MPa	285 MHV	18.4 µg/mm³	0.5 µg/mm³	ProFilCompositeFlow	2 %	65 MPa	130 MPa	3 mm of Al	3 mm

{8}------------------------------------------------

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	ElasticModulus	Intensity forCuring	Wavelengthfor Curing	Filler ParticleSizeDistribution	Sample Name	Working Time	Setting Time	Curing Time
IMICRYLComposite Flow(Lot No: 17126)	16.8 GPa	1200 mW/cm² -10 sec500 mW/cm² –20 sec	470 nm	0.7 μm	IMICRYL CompositeFlow (Lot No: 17126)	38 second	4 minute	20 second
ProFilComposite Flow	17.1 GPa	1200 mW/cm² -10 sec500 mW/cm² –20 sec	470 nm	0.7 μm	ProFil Composite Flow	35 second	4 minute 10second	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.

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.