Zircos-Com

K190139 · Bioden Co., Ltd. · EBF · Apr 24, 2020 · Dental

Device Facts

• Record ID: K190139
• Device Name: Zircos-Com
• Applicant: Bioden Co., Ltd.
• Product Code: EBF · Dental
• Decision Date: Apr 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Zircos-Com is a light-cured, radiopaque, reinforced hybrid composite resin used for anterior and posterior dental restorations. The device is supplied as a paste in a high-viscosity syringe. It is intended for use by dentists and dental specialists in a clinical setting. The clinician prepares the cavity, applies the composite material, and uses a standard light-curing unit (20-40 seconds) to polymerize the resin. The output is a hardened dental restoration that restores tooth structure, shape, and shade. The device benefits patients by providing a durable, aesthetic material for repairing dental defects or caries. Clinical decision-making is supported by the clinician's assessment of the patient's restorative needs.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility assessments (cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and genotoxicity per ISO 10993 standards) and verification of design specifications.

Technological Characteristics

Light-cured, radiopaque hybrid composite resin. Supplied in high-viscosity syringe. Curing time: 20-40 seconds. Compliant with ISO 4049. Materials are biocompatible per ISO 10993.

Indications for Use

Indicated for direct fillings of Class I to V restorations and shape/shade corrections in patients of all ages and genders requiring dental restorative procedures.

Regulatory Classification

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.

Predicate Devices

• Grandio SO (K102351)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

## 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
- 2. 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: [phone] Fax: [phone]

Email: [e-mail]

- 3. 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.

- 4. 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.
- 6. Clinical Test Conclusion

No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 7.

| Table 1 Comparison of Technology Characteristics | |
|--------------------------------------------------|--|
|--------------------------------------------------|--|

| N | Division | Bioden CO., Ltd | VOCO GmbH | Substantial<br>Equivalence<br>Discussion | |
|----------------|---------------|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 0 | | Zircos-Com | Grandio | | |
| 1 | Clinic<br>al | Indication<br>for<br>Use | Zircos-Com is used for<br>-Direct fillings of Class I to V<br>restorations<br>-Shape and shade corrections | Grandio SO is intended for<br>use as:<br>- class I to V fillings<br>- reconstruction of<br>traumatically affected<br>anteriors<br>- facetting of discolored<br>anteriors<br>- correction of shape and<br>shade for improved aesthetic<br>appearance<br>- locking, splinting of loose<br>anteriors<br>- repairing veneers<br>- restoration of deciduous<br>teeth<br>- core-build-up under crowns<br>- composite inlays | Similar with<br>predicate |
| 2 | | Intended<br>target<br>groups | Patients who are men of all<br>ages and sexes and need tooth<br>root canal treatment patient,<br>patient who cementing<br>restorations or cementing<br>temporary crowns and<br>bridges. | Patients who are men of all<br>ages and sexes and need tooth<br>root canal treatment patient,<br>patient who cementing<br>restorations or cementing<br>temporary crowns and<br>bridges. | Equivalence |
| 510(k) Summary | | | | | |
| 3 | | Structure | Image: Zircos-Com structure | Image: Grandio structure | Equivalence |
| 4 | | CE<br>Marking | | CE 0482 | Similar<br>Equivalent<br>products and<br>performance are<br>not identical, but<br>all are tested<br>according to ISO<br>3107 and passed<br>the reference<br>value. Also, it was<br>confirmed that the<br>result of checking<br>the sales history |
| 5 | Techn<br>ical | Curing<br>type | Light-curing type | Light-curing type | shows no adverse<br>effect in any<br>performance<br>problem. |
| 6 | | Curing<br>time | 20-40sec | 20-40sec | |
| 7 | | Compositi<br>on | Zircos-Com consists of a paste<br>system, which is delivered in<br>self-manufactured high<br>viscosity black syringe. | Grandio consists of a paste<br>system, which is delivered in<br>high viscosity black syringe. | Equivalence |
| 8 | Technica<br>l | Using<br>method<br>&procedu<br>re | 1. Shade selection<br>Clean tooth with pumice and<br>water to remove surface stains<br>or extraneous<br>plaque. Prior to isolation of<br>tooth, select the appropriate<br>shade. (We are recommend the<br>Vita shade guide)<br>2. Cavity preparation<br>Remove all amalgam or other<br>base materials that interfere<br>with operations.<br>3. Pulp protection<br>In deep cavities cover the<br>dentin close to the pulp with a<br>minimum amount of calcium<br>hydroxide liner leaving the<br>rest of cavity surface | 1. Preparation / Shade<br>selection<br>Clean the teeth to be treated<br>with a fluoride-free cleaning<br>paste. Mark occlusal contact<br>points(Posterior area); a<br>minimal seperation facilitates<br>the design of the approximal<br>contact and placing of the<br>matrix. Before anaesthesia,<br>moisten the Grandio shade<br>guide and match the shade to<br>the moist, clean tooth in<br>daylight<br>2. Drying<br>Ensure that the working field<br>is dry. Using a rubber dam is<br>recommended. | Equivalence |

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| 510(k) Summary | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| free bonding. Glass ionomer<br>or other eugenol-free<br>materials may be<br>used, if wished.<br>4. Enamel and dentin<br>treatment<br>Follow the manufacturer's<br>instructions regarding etching,<br>priming,<br>adhesive application and<br>curing.<br>5. Place composite<br>Allow Zircos-Com to reach<br>room temperature before<br>application.<br>For cavities in approximal<br>areas apply a matrix.<br>Using a translucent matrix is<br>beneficial.(smooth surfaces)<br>Apply the desired shade of<br>Zircos-Com and adapt it to the<br>cavity with a<br>suitable instrument. For<br>fillings of more than 2mm,<br>2mm apply and polymerize in<br>layers. Insert caps into the<br>opening of the dispenser<br>following the respective<br>instructions for use. Turn caps<br>in the desiresed direction and<br>remove the protective cover.<br>Apply Zircos-Com directly<br>into the cavity by slowly and<br>evenly pressing the levers of<br>the handle together.<br>6. Curing<br>Expose each area of<br>restoration surface to a high<br>intensity visible light source.<br>Hold the light guide tip as<br>close to the restorative as<br>possible during exposure.<br>Light cure for 20~40 seconds<br>with a standard light curing<br>unit. (If light curing unit<br>output is below 1,200mW/cm²,<br>as measured by a curing<br>radiometer, more time may be<br>needed.)<br>7. Finishing<br>Finish and polish using<br>conventional techniques. | 3. Cavity preparation<br>Generally, cavity preparation<br>should be carried out<br>according to the rules of the<br>adhesive filliing therapy, i.e.<br>minimally invasive to<br>conserve healthy tooth<br>substance. Bevel the enamel<br>margins on anteriors and<br>round off the preparation<br>margins on posteriors. Non-<br>carious cervical lesions do not<br>have to be prepared; thorough<br>cleaning sufficient here.<br>Afterwards, clean and dry the<br>cavity.<br>4. Lining<br>A Calcium hydroxide lining<br>should be applied in proximity<br>of the pulp. Place a layer of<br>stable cement over the lining.<br>Due to their fluoride release,<br>glass polyalkenoate(Glass<br>ionomer) materials are<br>recommended.<br>5. Bond material<br>Grandio is used in adhesive<br>technique with a<br>dentin/enamel bond. All light-<br>curing bonding materials may<br>be used. Follow the respective<br>instructions for use with<br>regards to preparation (etch<br>technique) and application<br>6. Application of Grandio<br>Let the material reach room<br>temperature before<br>application.<br>Place a matrix on cavities in<br>the approximal area. Using<br>translucent matrice is<br>advantageous( smooth<br>surfaces). Apply the chosen<br>shade of Grandio ( See shade<br>selection) and adapt it with a<br>suitable instrument. Apply and<br>polymerize fillings of more<br>than 2mm in layers.<br>7. Light-curing<br>Conventional polymerization<br>devices are suited for light-<br>curing this material. The light<br>output should be a minimum<br>of 500mw/cm2 on halogen<br>polymerization devices and<br>300mw/cm2 on LED devices.<br>The curing time |

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| | | 510(k) Summary | | | |
|----------------|-----------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | | | is a minimum of 20 sec per<br>layer, for opaque shade OA2<br>and OA3.5, a minimun of<br>40sec. Hold the light emission<br>tip of the device as close as<br>possible to the surface of the<br>filling. If the distance is more<br>than 5mm, the curing depth<br>may be compromised.<br>Incomplete curing may lead to<br>discoloration and pulpitiis-like<br>complaints.<br>8. Finishing<br>The filling can be finished and<br>polished immediately after<br>removing the shaping aids(e.g.<br>fine or extra fine diamond<br>burst, polishing disc), with<br>cooling provided. The margin<br>of the filling or the entire<br>tooth should be fluoridated as<br>a final step. Grandio can be<br>used for direct and indirect<br>and indirect inlays according<br>to customary methods. The<br>physical stability can be<br>improved by the usual<br>external(additional) Curing. | | |
| | | | 1. Do not store at high<br>temperature or intense light.<br>2. Keep in a cool<br>place.(1~30°C) | Store at temporarytures<br>between 4°C~ 23°C. If<br>refrigerated, the material must<br>be allowed to reach room<br>temperature before use. To<br>avoid exposure to light and<br>possible polymerization,<br>syringes should be closed<br>immediately after dispensing.<br>Do not use Grandio after the<br>expiry date. | Equivalence |
| 9 | Technical | Caution | 1. Zircos-Com must be<br>handled by dentists and dental<br>specialists according to the<br>instructions before using it.<br>2. Recommend the Rubber<br>dam for reduction of reaction<br>for use with<br>patients who have a history of<br>severe allergic reaction to<br>material.<br>3. Do not use to patients who<br>have rash on their skin,<br>dermatitis or histories of<br>hypersensitivity.<br>4. Stop applying this material<br>to the patients who have<br>symptoms of | - No known side effects.<br>Hypersensitive persons may<br>develop sensitivities.<br>- Phenolic substances,<br>especially eugenol-orthymol-<br>containing preparations<br>interfere with curing filling<br>composites. The use of zinc<br>oxide eugenol cements or<br>other eugenol-containing<br>materials in combination with<br>filling composites should be<br>avoided.<br>- Filling exposed to occlusal<br>forces should be checked at<br>least once a year for early<br>detection of changes. | Equivalence |
| 510(k) Summary | | | | | |
| | | | hypersensitivity during using.<br>5. This material is used only<br>to the oral tissue. Avoid<br>contact with eyes.<br>6. If accidental contact occurs<br>with eyes or skin, wash<br>immediately with much water<br>and seek medical advice.<br>7. Non-specialists must not<br>use this material. Do not use<br>this material for other<br>purposes.<br>8. Protective device for the<br>respiratory tract is highly<br>recommended before a<br>surgical operation.<br>9. Do not use after expiration<br>date. (within 3 years)<br>10. The product is dissolved in<br>alcohol when uncured or so<br>can cause<br>allergic reactions, applies a<br>su_cient curing time<br>according to the usage.<br>11. After curing light<br>according to the instruction,<br>remove the uncured<br>materials and wipe surface<br>with gauze again. | | |
| 1<br>0 | Biolog<br>ical | Biocompa<br>tibility<br>assessed | All fluid contact parts are ISO<br>4049 compliant. | All fluid contact parts are ISO<br>4049 compliant. | Equivalence |
| | equiva<br>lence | Side-<br>effect | There is no side-effect | There is no side-effect | Reference to the<br>above section 2.5<br>from MHRA |
| Conclusion | | | The Bioden's Zircos-Com and the VOCO GmBH's Grandio are equivalence to each<br>other in terms of Clinical, technical and biological characteristics following above<br>chart.<br>In aspect of clinical part, they all both are used for the same clinical condition, used<br>for the same intended purpose, and used at the same site in the body.<br>In aspect of technical part, they all both are used under the same conditions of use,<br>and have similar specifications and properties and have similar principles of operation<br>and critical performance requirements.<br>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.