Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and biocompatibility of a composite resin, with no mention of AI/ML, image processing, or data-driven algorithms.

Therapeutic

No
The device is a restorative material used for direct fillings, rather than a device designed to treat or cure a disease or condition. Its purpose is to repair and restore tooth structure.

Diagnostic

No
The device is described as a light-cured, radiopaque hybrid composite resin for direct fillings and restorations, not for diagnosing conditions. The performance studies also focus on biocompatibility, not diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "light-cured, radiopaque hybride composite resin," which is a physical material, not software. The performance studies also focus on biological and material properties.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "Direct fillings of Class I to V restorations" and "Shape and shade corrections." This describes a material used directly on the patient's oral tissue for restorative purposes.
Device Description: The description states it's a "light-cured, radiopaque hybride composite resin" for "anterior and posterior restorations." This further confirms its use as a dental filling material.
Lack of In Vitro Testing: The performance studies listed are primarily biological safety tests (cytotoxicity, sensitization, etc.) and not tests that would be performed on samples in vitro (outside the body) to diagnose or monitor a condition.
Anatomical Site: The anatomical site is "Oral tissue," indicating direct application to the patient.
Predicate Device: The predicate device is "Dental Composites and Filling Materials," which are not IVDs.

IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a material applied to the body for treatment, not a tool for analyzing samples from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

EBF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth

Indicated Patient Age Range

all ages

Intended User / Care Setting

dentists and dental specialists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical 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.
No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K102351

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

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

Summary

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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

2

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
--------------------------------------------------	--

| N | Division | Bioden CO., Ltd | VOCO GmbH | Substantial
Equivalence
Discussion | |
|----------------|---------------|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 0 | | Zircos-Com | Grandio | | |
| 1 | Clinic
al | Indication
for
Use | Zircos-Com is used for
-Direct fillings of Class I to V
restorations
-Shape and shade corrections | Grandio SO is intended for
use as:

class I to V fillings
reconstruction of
traumatically affected
anteriors
facetting of discolored
anteriors
correction of shape and
shade for improved aesthetic
appearance
locking, splinting of loose
anteriors
repairing veneers
restoration of deciduous
teeth
core-build-up under crowns
composite inlays | Similar with
predicate |
| 2 | | Intended
target
groups | Patients who are men of all
ages and sexes and need tooth
root canal treatment patient,
patient who cementing
restorations or cementing
temporary crowns and
bridges. | Patients who are men of all
ages and sexes and need tooth
root canal treatment patient,
patient who cementing
restorations or cementing
temporary crowns and
bridges. | Equivalence |
| 510(k) Summary | | | | | |
| 3 | | Structure | Image: Zircos-Com structure | Image: Grandio structure | Equivalence |
| 4 | | CE
Marking | | CE 0482 | Similar
Equivalent
products and
performance are
not identical, but
all are tested
according to ISO
3107 and passed
the reference
value. Also, it was
confirmed that the
result of checking
the sales history |
| 5 | Techn
ical | Curing
type | Light-curing type | Light-curing type | shows no adverse
effect in any
performance
problem. |
| 6 | | Curing
time | 20-40sec | 20-40sec | |
| 7 | | Compositi
on | Zircos-Com consists of a paste
system, which is delivered in
self-manufactured high
viscosity black syringe. | Grandio consists of a paste
system, which is delivered in
high viscosity black syringe. | Equivalence |
| 8 | Technica
l | Using
method
&procedu
re | 1. Shade selection
Clean tooth with pumice and
water to remove surface stains
or extraneous
plaque. Prior to isolation of
tooth, select the appropriate
shade. (We are recommend the
Vita shade guide)

Cavity preparation
Remove all amalgam or other
base materials that interfere
with operations.
Pulp protection
In deep cavities cover the
dentin close to the pulp with a
minimum amount of calcium
hydroxide liner leaving the
rest of cavity surface | 1. Preparation / Shade
selection
Clean the teeth to be treated
with a fluoride-free cleaning
paste. Mark occlusal contact
points(Posterior area); a
minimal seperation facilitates
the design of the approximal
contact and placing of the
matrix. Before anaesthesia,
moisten the Grandio shade
guide and match the shade to
the moist, clean tooth in
daylight
Drying
Ensure that the working field
is dry. Using a rubber dam is
recommended. | Equivalence |

5

6

510(k) Summary
free bonding. Glass ionomer
or other eugenol-free
materials may be
used, if wished.

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

7

		510(k) Summary
			is a minimum of 20 sec per
layer, for opaque shade OA2
and OA3.5, a minimun of
40sec. Hold the light emission
tip of the device as close as
possible to the surface of the
filling. If the distance is more
than 5mm, the curing depth
may be compromised.
Incomplete curing may lead to
discoloration and pulpitiis-like
complaints.

Finishing
The filling can be finished and
polished immediately after
removing the shaping aids(e.g.
fine or extra fine diamond
burst, polishing disc), with
cooling provided. The margin
of the filling or the entire
tooth should be fluoridated as
a final step. Grandio can be
used for direct and indirect
and indirect inlays according
to customary methods. The
physical stability can be
improved by the usual
external(additional) Curing. | | |
| | | | 1. Do not store at high
temperature or intense light.
Keep in a cool
place.(130°C) | Store at temporarytures
between 4°C 23°C. If
refrigerated, the material must
be allowed to reach room
temperature before use. To
avoid exposure to light and
possible polymerization,
syringes should be closed
immediately after dispensing.
Do not use Grandio after the
expiry date. | Equivalence |
| 9 | Technical | Caution | 1. Zircos-Com must be
handled by dentists and dental
specialists according to the
instructions before using it.
Recommend the Rubber
dam for reduction of reaction
for use with
patients who have a history of
severe allergic reaction to
material.
Do not use to patients who
have rash on their skin,
dermatitis or histories of
hypersensitivity.
Stop applying this material
to the patients who have
symptoms of | - No known side effects.
Hypersensitive persons may
develop sensitivities.

Phenolic substances,
especially eugenol-orthymol-
containing preparations
interfere with curing filling
composites. The use of zinc
oxide eugenol cements or
other eugenol-containing
materials in combination with
filling composites should be
avoided.
Filling exposed to occlusal
forces should be checked at
least once a year for early
detection of changes. | Equivalence |
| 510(k) Summary | | | | | |
| | | | hypersensitivity during using.

This material is used only
to the oral tissue. Avoid
contact with eyes.
If accidental contact occurs
with eyes or skin, wash
immediately with much water
and seek medical advice.
Non-specialists must not
use this material. Do not use
this material for other
purposes.
Protective device for the
respiratory tract is highly
recommended before a
surgical operation.
Do not use after expiration
date. (within 3 years)
The product is dissolved in
alcohol when uncured or so
can cause
allergic reactions, applies a
su_cient curing time
according to the usage.
After curing light
according to the instruction,
remove the uncured
materials and wipe surface
with gauze again. | | |
| 1
0 | Biolog
ical | Biocompa
tibility
assessed | All fluid contact parts are ISO
4049 compliant. | All fluid contact parts are ISO
4049 compliant. | Equivalence |
| | equiva
lence | Side-
effect | There is no side-effect | There is no side-effect | Reference to the
above section 2.5
from MHRA |
| Conclusion | | | The Bioden's Zircos-Com and the VOCO GmBH's Grandio are equivalence to each
other in terms of Clinical, technical and biological characteristics following above
chart.
In aspect of clinical part, they all both are used for the same clinical condition, used
for 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 operation
and critical performance requirements.
In aspect of biological part, they all both use the same materials or substances in | | |

8

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.