The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior.Medi White Pearl) are visible light-cure, radiopaque restorative material (Composite) with high polishingability, excellent physical properties and are designed for anterior and posterior restorations. The subject devices formulated from multifunctional methacrylate monomer-based resin, photo initiator, silanated inorganic filler and pigments. Available in multiple shades. These restoratives provides high strength and low wear for durability. They are packaged in traditional syringes and Pre-Loaded Tips.

AI/ML Overview

The provided FDA 510(k) document (K170873) is for a dental restorative material, not an AI-powered diagnostic device. Therefore, the typical acceptance criteria and study designs relating to AI performance metrics (like sensitivity, specificity, F1-score, reader studies, etc.) are not applicable here.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on physical and mechanical properties, chemical composition, and biocompatibility, as per the requirements for Class II medical devices like tooth shade resin materials.

Here's a breakdown of the relevant information provided, adapted to the context of a material rather than an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with ISO 4049:2009 for "Dentistry - Polymer-based restorative materials" and substantial equivalence to the predicate device (Clearfil Majesty ES-2) across various physical and performance properties. The "reported device performance" refers to the measured values for the subject devices and the predicate device.

Property	Acceptance Criteria / Predicate Performance (Clearfil Majesty ES-2)	Reported Device Performance (Subject Devices)
Radiopacity	2.13 (±0.08) mmAl	2.10 (±0.04) mmAl
Compressive strength	341 (±0.11) MPa	338-352 (±0.08) MPa
Elasticity modulus	14.8 (±0.06) GPa	15.1 (±0.07) GPa
Fracture Toughness	1.68 (±0.10) MPa.m1/2	1.71 (±0.09) MPa.m1/2
Surface Hardness (KHN)	71.07 ± 2.24	75.03 ± 2.10
Flexural Strength	127 (±10) MPa	131 (±14) MPa
Flexural Modulus	11.6 (±0.8) MPa	10.6 (±0.6) MPa
Water Sorption	19.3 (±1.9) µg/mm3	23.1 (±2.1) µg/mm3
Water Solubility	0.8 (±0.8) µg/mm3	1.0 (±0.7) µg/mm3
Intensity for curing (photo-initiated resins)	1200-2000 mW/cm2	1200-2000 mW/cm2
Wavelength for curing (photo-initiated resins)	400-520 nm	400-520 nm
Maximum absorbance	450-480 (468) nm	450-480 (468) nm
Depth of Cure	2.40 (±0.02) mm	2.22 (±0.03) mm
Curing time	40 s/2mm	40 s/2mm
ISO Standard Compliance	ISO 4049: 2009	Complies with ISO 4049: 2009
Chemical Ingredients	Methacrylate-based resin, photo initiator, fillers and pigments.	Methacrylate-based resin, photo initiator, fillers and pigments; all ingredients common with predicate.
Biocompatibility	Ingredients used in predicate, no reported problems/recalls.	Ingredients used in predicate, no reported problems/recalls.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample size (n-value) for each physical and mechanical property test. It provides mean values and standard deviations, which implies repeat measurements were taken, but the exact number of samples per test is not detailed.
Data Provenance: The data is generated from non-clinical performance testing of the subject devices themselves, and for comparison, the predicate device. The country of origin for the data generation and whether it's retrospective or prospective is not specified, but it would typically be prospective laboratory testing conducted by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable. The "ground truth" for material properties is established through standardized laboratory testing methods (e.g., ISO 4049:2009), not through expert clinical consensus or interpretation in the way AI models are evaluated.

4. Adjudication Method for the Test Set

This question is not applicable as there is no expert adjudication for material properties. Compliance is determined by objective measurements against established international standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

This question is not applicable. MRMC studies are used for evaluating diagnostic accuracy with human readers, which is not relevant for a dental restorative material.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

This question is not applicable. This is not an AI algorithm. The performance data presented are "standalone" in the sense that they describe the intrinsic physical and chemical properties of the material itself.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements obtained through standardized laboratory testing protocols as defined by ISO 4049:2009 and comparison to the well-established performance of a legally marketed predicate device.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI model, therefore, no training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no AI model or training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a non-clinical performance testing program based on the international standard ISO 4049:2009 (Dentistry - Polymer-based restorative materials). The manufacturer tested the physical and mechanical properties of the subject devices (Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl) and compared them to a legally marketed predicate device, Clearfil Majesty ES-2, which also complies with ISO 4049:2009.

The study demonstrated that:

The subject devices' measured physical properties (e.g., radiopacity, compressive strength, flexural strength, depth of cure, water sorption, water solubility) fall within very similar values to those of the predicate device.
The chemical ingredients of the subject devices are all used in the predicate devices.
The subject devices, like the predicate, comply with ISO 4049:2009.
The biocompatibility is considered acceptable because the chemical ingredients are common to the predicate device, which has no reported post-market adverse events.

These findings support the conclusion that the subject devices are substantially equivalent in performance to the predicate device and thus meet the necessary acceptance criteria for marketing.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2017

SwissMediTec GmbH Kurosh Sohi Senior Director/ OA Gfellen 26 Finsterwald. 6162 Luzern SWITZERLAND

Re: K170873

Trade/Device Name: Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: July 21, 2017 Received: August 2, 2017

Dear Kurosh Sohi:

This letter corrects our substantially equivalent letter of October 2, 2017.

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.

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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 (DICE) 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 (DICE) 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,

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for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170873

Device Name

Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl

Indications for Use (Describe)

1. Direct anterior and posterior restorations (including occlusal surfaces)
1. Direct veneers
1. Correction of tooth position and tooth shape
1. Indirect restorations including inlays, onlays and veneers
1. Intraoral repairs of fractured restorations
1. Core build-ups
1. Splinting

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5.1 Device Description

(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.

They are classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF) according to CFR-872.

(b) Classification. Class II.

Physical and mechanical properties of the subject devices (Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) are evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative materials). According to ISO 4049: 2009, the subject devices are classified into the following:

Type II: Polymer-based restorative materials;
Class 2: materials whose setting is effected by light;
Group I: materials whose use requires the energy to be applied intra-orally.

Section 5.2 Indication for Use Statement

The Indication for Use of the subject devices (Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter.Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) were prepared based on that of the predicate device. Therefore, the intended purposes of the subject devices are substantially equivalent to those of the predicate device (Clearfil Majesty ES-2).

They are intended for the following indications:

1-Direct anterior and posterior restorations teeth (including occlusal surfaces)
2-Direct veneers

3-Correction of tooth position and tooth shape.

4-Indirect restorations including inlays,onlays and veneers

5-Intraoral repairs of fractured restorations

6-Core build-ups

7-Splinting

Technological characteristics of device

It can be said that subject devices (Medi Classic, Medi Pearl,Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl), are substantially equivalent in performance as well as those of the predicate device with the following characteristics:

1-Chemical ingredients

All the chemical ingredients of the subject devices (Medi Classic, Medi Classic, Medi Pearl,Medi Jupiter Medi Opaque Plus, Medi Opaque Posterior, Medi White Peal) are used in the predicate devices, indicating the subject devices are substantially equivalent to the predicate device.

Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.

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2-Performance

Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject devices (Medi galaxy Flow, Medi Classic, Medi Pearl, Medi Opaque Plus, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl) and the predicate device comply with ISO 4049:2009 indicating that the subject devices are substantially equivalent in performance to the predicate device (Clearfil Majesty ES-2).

3-Biocompatibility

All the chemical ingredients of the subject devices(Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl), have been used in the predicate device.

Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was considered that the subject devices are substantially equivalent in performance to the predicate device.

Section 5.3 Substantial Equivalence Discussion

The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior.Medi White Pearl) are similar to predicate device in terms of indication for use. design, chemical composition, physical properties and performance etc. The subject devices consist of multifunctional methacrylate resin base composite, as is the predicate device (Clearfi Majestx ES-2). The compressive strength, flexural strength, depth of cure, particle size range and radiopacity of subject devices and Predicate Device Clearfil Majesty ES-2 fall within very similar values (Table.1). The physical properties and performance of subject devices are not significantly different from the predicate device (Clearfil Majesty ES-2), as indicated by non-clinical performance testing. The variety of shades and sizes are different between subject device and predicate device.

Table 1 Comparison of Subject Devices and Predicate Devices
DescriptiveInformation	Subject Devices	Predicate Device	Summary
Device Name	• Medi galaxy Flow• Medi Classic• Medi Pearl• Medi Jupiter• Medi Opaque Plus• Medi Opaque Posterior• Medi White Pearl	• Clearfil Majesty ES-2	-
Manufacturer	Swissmeditec GmbH	Kuraray Noritake Dental Inc.	-
510(k)	To be assigned	K121583	-
ApplicationProperties/Delivery form	It is packaged in traditional syringesor Pre-loaded tips (PLTs)Accessory: Shade Guide	It is packaged in traditional syringesor Pre-loaded tips (PLTs)Accessory: Shade Guide	-
Intended user	Dental professionals	Dental professionals	-
Indications for	1-Direct anterior and posterior restorations teeth (including occlusal surfaces)2-Direct veneers3-Correction of tooth position and tooth shape.	1- Direct restorations for all cavity classes in anterior and posterior teeth2- Direct veneers3- Correction of tooth position and tooth shape (e.g. diastema closure,	Indications of the subject devices are the
use	4-Indirect restorations includinginlays, onlays and veneers5-Intraoral repairs of fracturedrestorations6-Core build-ups7-Splinting	dwarfed tooth, etc.)4-Intraoral repairs of fracturedrestorations	same as thepredicate device.
Design	Screw top 2.5ml(4.5g) syringe andPre Loaded Tube 0.3 g	Screw top 2.0ml (3.6g) syringe andPre Loaded Tube 0.25 g	Subject devicescontain 25%more compositethan predicatedevice but havethe same design
Composition ofMaterials	Methacrylate-based resin, photoinitiator, fillers and pigments.	Methacrylate-based resin, photo Chemicallysimilar to thepredicate device.
Physical andPerformanceProperties	1-Radiopacity: 2.10 (±0.04) mm Al2-Compressive strength: 338-352(±0.08) MPa3-Elasticity modulus: 15.1(±0.07)GPa4-Fracture Toughness: 1.71 (±0.09)MPa.m1/25-Surface Hardness (KHN): 75.03 ±2.106-Flexural Strength: 131 (±14) MPa7-Flexural Modulus: 10.6 (±0.6) MPa8-Water Sorption: 23.1 (±2.1)µg/mm39-Water Solubility: 1.0 (±0.7)µg/mm310-Intensity for curing (for photo -initiated resins):1200-2000 mW/cm211-wavelength for curing (forphotoinitiated resins):400-520 nm12-Maximum absorbance 450-480(468)nm13-Depth of Cure: 2.22 (±0.03) mm14-Curing time: 40 s/2mm	1-Radiopacity: 2.13 (±0.08) mmAl2-Compressive strength: 341(±0.11)MPa3-Elastic modulus: 14.8(±0.06) GPa4-Fracture Toughness: 1.68 (±0.10)MPa.m1/25-Surface Hardness (KHN): 71.07 ±2.246-Flexural Strength: 127 (±10) MPa7-Flexural Modulus: 11.6 (±0.8) MPa8-Water Sorption: 19.3 (±1.9)µg/mm39-Water Solubility: 0.8(±0.8)µg/mm310-Intensity for curing (for photo -initiated resins): 1200-2000 mW/cm211-wavelength for curing (forphotoinitiated resins) :400-520nm12-Maximum absorbance 450-480(468) nm13-Depth of Cure: 2.40 (±0.02) mm14-Curing time: 40 s/2mm	Physical andperformanceproperties datasupportsubstantialequivalence ofthe Subjectdevices whencompared to thepredicate device.
FDARecognizedStandards	ISO 4049: 2009	ISO 4049: 2009	4-181
Shelf Life	36 month shelf life, room temperature	36 month shelf life, room temperature	Same

Table 1 Comparison of Subject Devices and Predicate Devices

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SwissMediTec GmbH Traditional 510(K)

CONCLUSIONS

The indications and technological characteristics of subject devices (Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) are

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substantially equivalent to predicate device(Clearfil Majesty ES-2). Therefore, subject devices are substantially equivalent to the identified predicate device.

Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was considered that the subiect devices are Substantially Equivalent in effectiveness to the predicate device

Section 5.4 Technological Characteristics

1-Chemical ingredients

All the chemical ingredients of the subject devices (Medi Classic, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) are used in the predicate devices, indicating the subject devices are substantially equivalent to the predicate device.

Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.

2-Performance

Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject devices(Medi galaxy Flow, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) and the predicate device comply with ISO 4049:2009 indicating that the subject devices are substantially equivalent in performance to the predicate device.

3-Biocompatibility

4-Substantial Equivalence Discussion

The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter, Medi Opaque Plus, Medi Opaque Posterior Medi White Pearl) are similar to predicate device in terms of indication for use, design, chemical composition, physical properties, performance, etc. The subject devices (Medi galaxy Flow. Medi Classic. Medi Pearl.Medi Jupiter.Medi Opaque Plus. Medi Opaque Posterior,Medi White Pearl) consist of multifunctional methacrylate resin base composite , as is the predicate device. The compressive strength, flexural strength, depth of cure, particle size range and radiopacity of subject devices and Predicate Device Clearfil Majesty ES-2 fall within very similar values. The physical properties and performance of subject devices are not significantly different from the predicate device (Clearfil Majesty ES-2), as indicated by non-clinical performance testing. The variety of shades and sizes are different between subject device and predicate device.

Section 5.5 Performance Data

Curing time evaluated according to ISO 10650-1

Light Source	Curing time/sec.	Wavelength range and light intensity	Depth of cure/mm
	20		1.5

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SwissMediTec GmbH Traditional 510(K)

40	2.0
ባበLU	ﻝ، ﻠ
40	2.0

	Cure time/Sec.	Depth of cure/mm
	A1, A2, A3, A3.5, A4, B1, B2, B3,C2, C3, C4, D2, D3, D4, BL1, BL2,E1, E2, E3	OA2, OA3, OA4
ConventionalHalogen	20	1.5
		1.0
LED	20	1.5
		1.0

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.