Zircos-com is light-cured, radiopaque hybride composite resin. Zircos-Com is hybride composite resin for anterior and posterior restorations. Zircos-Com is reinforced filler composite.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific performance criteria.

Instead, the document is a 510(k) Summary for a dental composite material called "Zircos-Com," aiming to demonstrate its substantial equivalence to a predicate device ("Grandio SO"). The focus is on comparing the proposed device's characteristics (clinical, technical, and biological) to a legally marketed predicate device, rather than establishing numerical performance metrics against specific acceptance criteria.

The "Non-Clinical Test Conclusion" section (Item 5 on page 4) lists several biocompatibility tests conducted according to ISO standards, but these are for safety and biological compatibility, not functional performance. The conclusion states these tests verify the device "met all design specifications" and was "Substantially Equivalent (SE) to the predicate device," but no specific performance values or acceptance criteria are presented.

The "Clinical Test Conclusion" section (Item 6 on page 4) explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information based on the provided text, as it does not contain:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set, data provenance, ground truth establishment for a performance study.
Number of experts or their qualifications for establishing ground truth.
Adjudication method for a test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
Information on a standalone algorithm performance study.
Type of ground truth used for performance evaluation.
Sample size for a training set or how its ground truth was established.

The document's purpose is to show that a new device is as safe and effective as an existing one, not to quantify its performance against a new set of criteria in a clinical or standalone study.

Summary

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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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

April 24, 2020

Bioden Co., Ltd % Chris Park General Manager Med.com 1809 Holland Dr Somerset, New Jersey 08873

Re: K190139

Trade/Device Name: Zircos-Com Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 22, 2020 Received: January 28, 2020

Dear Chris Park:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190139

Device Name

Trade Name: Dental Composites and Filling Materials Common Name: Dental Composites and Filling Materials Trade name: Zircos-Com

Indications for Use (Describe)

Direct fillings of Class I to V restorations
Shape and shade corrections

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92

The assigned 510(k) Number: K190139

1. Date of Preparation: 08, April, 2020
1. Sponsor Identification BIODEN Co.,Ltd Address: #B-803 119, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea of Republic, 08589 Establishment Registration Number: Not yet registered for the Number Contact Person: Lee Chang Taek Position: Representative Tel: +82-2-6292-2840 Fax: 82-2-6292-2846

Email: biodenzircose@gmail.com

1. Identification of Proposed Device Trade Name: Dental Composites and Filling Materials Common Name: Dental Composites and Filling Materials Trade name: Zircos-Com
  Regulatory Information

Classification Name: Tooth Shade Resin Classification: 2

Product Code: Class II Device / EBF (21 CFR 872.3690) Review Panel: Dental Indication for use Statement:

Direct fillings of Class I to V restorations ●
. Shape and shade corrections

Device Description Zircos-com is light-cured, radiopaque hybride composite resin. Zircos-Com is hybride composite resin for anterior and posterior restorations. Zircos-Com is reinforced filler composite.

1. Identification of Predicate Device(s)
  Predicate Device
510(k) number: K102351
Name: Dental Composites and Filling Materials
Model: Grandio SO
Company: VOCO GmbH
Classification: 2

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ર. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, including
Cytotoxicity per ISO 10993-5:2009;
Intracutaneous Reactivity Test per ISO 10993-10:2010;
Sensitization Test per ISO 10993-10:2010
Acute Systematic Toxicity per ISO 10993-11:2006;
Genotoxicity Tests per ISO 10993-3:2014.
1. Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 7.

Table 1 Comparison of Technology Characteristics
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N	Division	Bioden CO., Ltd	VOCO GmbH	SubstantialEquivalenceDiscussion
0		Zircos-Com	Grandio
1	Clinical	IndicationforUse	Zircos-Com is used for-Direct fillings of Class I to Vrestorations-Shape and shade corrections	Grandio SO is intended foruse as:- class I to V fillings- reconstruction oftraumatically affectedanteriors- facetting of discoloredanteriors- correction of shape andshade for improved aestheticappearance- locking, splinting of looseanteriors- repairing veneers- restoration of deciduousteeth- core-build-up under crowns- composite inlays	Similar withpredicate
2		Intendedtargetgroups	Patients who are men of allages and sexes and need toothroot canal treatment patient,patient who cementingrestorations or cementingtemporary crowns andbridges.	Patients who are men of allages and sexes and need toothroot canal treatment patient,patient who cementingrestorations or cementingtemporary crowns andbridges.	Equivalence
510(k) Summary
3		Structure	Image: Zircos-Com structure	Image: Grandio structure	Equivalence
4		CEMarking		CE 0482	SimilarEquivalentproducts andperformance arenot identical, butall are testedaccording to ISO3107 and passedthe referencevalue. Also, it wasconfirmed that theresult of checkingthe sales history
5	Technical	Curingtype	Light-curing type	Light-curing type	shows no adverseeffect in anyperformanceproblem.
6		Curingtime	20-40sec	20-40sec
7		Composition	Zircos-Com consists of a pastesystem, which is delivered inself-manufactured highviscosity black syringe.	Grandio consists of a pastesystem, which is delivered inhigh viscosity black syringe.	Equivalence
8	Technical	Usingmethod&procedure	1. Shade selectionClean tooth with pumice andwater to remove surface stainsor extraneousplaque. Prior to isolation oftooth, select the appropriateshade. (We are recommend theVita shade guide)2. Cavity preparationRemove all amalgam or otherbase materials that interferewith operations.3. Pulp protectionIn deep cavities cover thedentin close to the pulp with aminimum amount of calciumhydroxide liner leaving therest of cavity surface	1. Preparation / ShadeselectionClean the teeth to be treatedwith a fluoride-free cleaningpaste. Mark occlusal contactpoints(Posterior area); aminimal seperation facilitatesthe design of the approximalcontact and placing of thematrix. Before anaesthesia,moisten the Grandio shadeguide and match the shade tothe moist, clean tooth indaylight2. DryingEnsure that the working fieldis dry. Using a rubber dam isrecommended.	Equivalence

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510(k) Summary
free bonding. Glass ionomeror other eugenol-freematerials may beused, if wished.4. Enamel and dentintreatmentFollow the manufacturer'sinstructions regarding etching,priming,adhesive application andcuring.5. Place compositeAllow Zircos-Com to reachroom temperature beforeapplication.For cavities in approximalareas apply a matrix.Using a translucent matrix isbeneficial.(smooth surfaces)Apply the desired shade ofZircos-Com and adapt it to thecavity with asuitable instrument. Forfillings of more than 2mm,2mm apply and polymerize inlayers. Insert caps into theopening of the dispenserfollowing the respectiveinstructions for use. Turn capsin the desiresed direction andremove the protective cover.Apply Zircos-Com directlyinto the cavity by slowly andevenly pressing the levers ofthe handle together.6. CuringExpose each area ofrestoration surface to a highintensity visible light source.Hold the light guide tip asclose to the restorative aspossible during exposure.Light cure for 20~40 secondswith a standard light curingunit. (If light curing unitoutput is below 1,200mW/cm²,as measured by a curingradiometer, more time may beneeded.)7. FinishingFinish and polish usingconventional techniques.	3. Cavity preparationGenerally, cavity preparationshould be carried outaccording to the rules of theadhesive filliing therapy, i.e.minimally invasive toconserve healthy toothsubstance. Bevel the enamelmargins on anteriors andround off the preparationmargins on posteriors. Non-carious cervical lesions do nothave to be prepared; thoroughcleaning sufficient here.Afterwards, clean and dry thecavity.4. LiningA Calcium hydroxide liningshould be applied in proximityof the pulp. Place a layer ofstable cement over the lining.Due to their fluoride release,glass polyalkenoate(Glassionomer) materials arerecommended.5. Bond materialGrandio is used in adhesivetechnique with adentin/enamel bond. All light-curing bonding materials maybe used. Follow the respectiveinstructions for use withregards to preparation (etchtechnique) and application6. Application of GrandioLet the material reach roomtemperature beforeapplication.Place a matrix on cavities inthe approximal area. Usingtranslucent matrice isadvantageous( smoothsurfaces). Apply the chosenshade of Grandio ( See shadeselection) and adapt it with asuitable instrument. Apply andpolymerize fillings of morethan 2mm in layers.7. Light-curingConventional polymerizationdevices are suited for light-curing this material. The lightoutput should be a minimumof 500mw/cm2 on halogenpolymerization devices and300mw/cm2 on LED devices.The curing time

510(k) Summary

free bonding. Glass ionomeror other eugenol-freematerials may beused, if wished.4. Enamel and dentintreatmentFollow the manufacturer'sinstructions regarding etching,priming,adhesive application andcuring.5. Place compositeAllow Zircos-Com to reachroom temperature beforeapplication.For cavities in approximalareas apply a matrix.Using a translucent matrix isbeneficial.(smooth surfaces)Apply the desired shade ofZircos-Com and adapt it to thecavity with asuitable instrument. Forfillings of more than 2mm,2mm apply and polymerize inlayers. Insert caps into theopening of the dispenserfollowing the respectiveinstructions for use. Turn capsin the desiresed direction andremove the protective cover.Apply Zircos-Com directlyinto the cavity by slowly andevenly pressing the levers ofthe handle together.6. CuringExpose each area ofrestoration surface to a highintensity visible light source.Hold the light guide tip asclose to the restorative aspossible during exposure.Light cure for 20~40 secondswith a standard light curingunit. (If light curing unitoutput is below 1,200mW/cm²,as measured by a curingradiometer, more time may beneeded.)7. FinishingFinish and polish usingconventional techniques.

3. Cavity preparationGenerally, cavity preparationshould be carried outaccording to the rules of theadhesive filliing therapy, i.e.minimally invasive toconserve healthy toothsubstance. Bevel the enamelmargins on anteriors andround off the preparationmargins on posteriors. Non-carious cervical lesions do nothave to be prepared; thoroughcleaning sufficient here.Afterwards, clean and dry thecavity.4. LiningA Calcium hydroxide liningshould be applied in proximityof the pulp. Place a layer ofstable cement over the lining.Due to their fluoride release,glass polyalkenoate(Glassionomer) materials arerecommended.5. Bond materialGrandio is used in adhesivetechnique with adentin/enamel bond. All light-curing bonding materials maybe used. Follow the respectiveinstructions for use withregards to preparation (etchtechnique) and application6. Application of GrandioLet the material reach roomtemperature beforeapplication.Place a matrix on cavities inthe approximal area. Usingtranslucent matrice isadvantageous( smoothsurfaces). Apply the chosenshade of Grandio ( See shadeselection) and adapt it with asuitable instrument. Apply andpolymerize fillings of morethan 2mm in layers.7. Light-curingConventional polymerizationdevices are suited for light-curing this material. The lightoutput should be a minimumof 500mw/cm2 on halogenpolymerization devices and300mw/cm2 on LED devices.The curing time

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		510(k) Summary
			is a minimum of 20 sec perlayer, for opaque shade OA2and OA3.5, a minimun of40sec. Hold the light emissiontip of the device as close aspossible to the surface of thefilling. If the distance is morethan 5mm, the curing depthmay be compromised.Incomplete curing may lead todiscoloration and pulpitiis-likecomplaints.8. FinishingThe filling can be finished andpolished immediately afterremoving the shaping aids(e.g.fine or extra fine diamondburst, polishing disc), withcooling provided. The marginof the filling or the entiretooth should be fluoridated asa final step. Grandio can beused for direct and indirectand indirect inlays accordingto customary methods. Thephysical stability can beimproved by the usualexternal(additional) Curing.
			1. Do not store at hightemperature or intense light.2. Keep in a coolplace.(1~30°C)	Store at temporaryturesbetween 4°C~ 23°C. Ifrefrigerated, the material mustbe allowed to reach roomtemperature before use. Toavoid exposure to light andpossible polymerization,syringes should be closedimmediately after dispensing.Do not use Grandio after theexpiry date.	Equivalence
9	Technical	Caution	1. Zircos-Com must behandled by dentists and dentalspecialists according to theinstructions before using it.2. Recommend the Rubberdam for reduction of reactionfor use withpatients who have a history ofsevere allergic reaction tomaterial.3. Do not use to patients whohave rash on their skin,dermatitis or histories ofhypersensitivity.4. Stop applying this materialto the patients who havesymptoms of	- No known side effects.Hypersensitive persons maydevelop sensitivities.- Phenolic substances,especially eugenol-orthymol-containing preparationsinterfere with curing fillingcomposites. The use of zincoxide eugenol cements orother eugenol-containingmaterials in combination withfilling composites should beavoided.- Filling exposed to occlusalforces should be checked atleast once a year for earlydetection of changes.	Equivalence
510(k) Summary
			hypersensitivity during using.5. This material is used onlyto the oral tissue. Avoidcontact with eyes.6. If accidental contact occurswith eyes or skin, washimmediately with much waterand seek medical advice.7. Non-specialists must notuse this material. Do not usethis material for otherpurposes.8. Protective device for therespiratory tract is highlyrecommended before asurgical operation.9. Do not use after expirationdate. (within 3 years)10. The product is dissolved inalcohol when uncured or socan causeallergic reactions, applies asu_cient curing timeaccording to the usage.11. After curing lightaccording to the instruction,remove the uncuredmaterials and wipe surfacewith gauze again.
10	Biological	Biocompatibilityassessed	All fluid contact parts are ISO4049 compliant.	All fluid contact parts are ISO4049 compliant.	Equivalence
	equivalence	Side-effect	There is no side-effect	There is no side-effect	Reference to theabove section 2.5from MHRA
Conclusion			The Bioden's Zircos-Com and the VOCO GmBH's Grandio are equivalence to eachother in terms of Clinical, technical and biological characteristics following abovechart.In aspect of clinical part, they all both are used for the same clinical condition, usedfor the same intended purpose, and used at the same site in the body.In aspect of technical part, they all both are used under the same conditions of use,and have similar specifications and properties and have similar principles of operationand critical performance requirements.In aspect of biological part, they all both use the same materials or substances in

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Subject device, Based on the table above, the intended use of Zircos-Com is identical to the other equivalent devices and there is no significant clinical difference in the performance and stability when comparing the technical characteristics and biological natures.

Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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.