(78 days)
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No
The summary describes a light-cured glazing material and does not mention any computational or analytical functions that would typically involve AI/ML.
No.
The device is used for characterization, smoothness, and wear resistance of dental materials, not for treating any disease, injury, or medical condition in a patient.
No
The device is described as a light-cured glazing material used for characterization, surface smoothness, and wear resistance of dental restorations and artificial teeth. Its intended uses (characterization, obtaining surface smoothness and wear resistance) do not involve diagnosing a disease or condition. The performance studies focus on material properties rather than diagnostic accuracy.
No
The device description clearly states "Optiglaze Color is a light-cured glazing and for characterization..." and describes it as a "material". This indicates a physical substance, not software. The performance studies also focus on material properties like depth of cure, color stability, and surface hardness.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this product is used for characterizing and improving the surface of dental restorations and prosthetics (composite restorations, acrylic denture base, artificial acrylic teeth). These are materials, not human specimens.
- The purpose of an IVD is to provide information about a physiological or pathological state. This device is used for aesthetic and functional improvements of dental materials, not for diagnosing or monitoring a medical condition.
The description focuses on the physical properties and application of the material on dental devices, which is consistent with a dental material product, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
For characterization of direct and indirect composite restorations, acrylic denture base and a. artificial acrylic teeth.
For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.
Product codes (comma separated list FDA assigned to the subject device)
EBD
Device Description
Optiglaze Color is a light-cured glazing and for characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth, and also for obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth. The material is available in 17 shades.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing includes:
- Appearance .
- Depth of cure ●
- Color stability after irradiation
- Surface hardness
- Application characteristics .
- ਉਂ Packaging
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
KI33836
Section 5 - 510(k) Summary
Image /page/0/Picture/2 description: The image shows the text "MAR - 6 2014" in the upper portion of the image. Below the date is the text "CCI" in a bold, sans-serif font. The text is black and the background is white.
GC AMERICA INC..
3737 W 127th STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 926-9100
www.gcamerica.com
-
- Submitter Information:
GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803
- Submitter Information:
| Contact Person: | Mark Heiss, D.D.S. |
|---|---|
| Phone: | (708) 926-3090 |
| Fax: | (708) 926-9100 |
Date Prepared: December 13, 2013
-
- Device Name ..
| Proprietary Name: | Optiglaze Color |
|---|---|
| Classification Name: | Coating, Filling Material, Resin |
| Device Classification: | Class II, 872.3310 |
| Product Code: | EBD |
- Predicate Devices: 3.
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IN LAND SER E E E LAND SERVED LAUN
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.
FINALERS CLASS CLASS COLLECT CAME CA
AND OF CHININGS CHARACT CHARACT COLLEGIAL COLLEGIAL COLLEGION COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT CARD AND
. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | C
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- Description of Device: 4.
-
- Optiglaze Color is a light-cured glazing and for characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth, and also for obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth. The material is available in 17 shades.
-
- Indications for Use:
- For characterization of direct and indirect composite restorations, acrylic denture base and a. artificial acrylic teeth.
- b. For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.
7. Technological characteristics:
All the components of the applicant device, Optiglaze Color, have already been used in the predicate devices. The curing mechanism of the predicate devices is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator system.
-
- Substantial equivalence:
The applicant device complies with all the requirements of ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation & testing.
- Substantial equivalence:
The curing mechanism of the new and predicate devices is substantially equivalent in principle. Therefore, the new and predicate devices are the same in function, and similar in composition and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate devices.
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Page 2
-
. 9. Differences
The following differences may be noted between the predicate device and Optiglaze Color: · Optiglaze Color has higher surface hardness and comes in multiple shades. -
- Performance Bench Tests
It is confirmed that the device conforms to the required specifications and is suitable for its intended use. Performance testing includes:
- Performance Bench Tests
-
Appearance .
-
Depth of cure ●
-
Color stability after irradiation �
-
Surface hardness �
-
Application characteristics .
-
ਉਂ Packaging
Complete set: A-Plus 2.6ml, B-Plus 2.6ml, C-Plus 2.6ml, White 2.6ml, Ivory-White 2.6ml, Yellow 2.6ml, Orange 2.6ml, Pink-Orange 2.6ml, Pink 2.6ml, Red-Brown 2.6ml, Olive 2.6ml, Lavender 2.6ml, Grey 2.6ml, Blue 2.6ml, Red 2.6ml, Clear 5ml, Clear HV 5ml
Accessories Disposable Pallet Flat Brush Round Brush Brush Holder Box
-
- Shelf Life Evaluation and Storage Conditions:
- Shelf Life 3 years -
- Store in a cool and dark place. 4-25°C (39.2 77.0°F)
| Applicant device | Comparative device | |
|---|---|---|
| Product | ||
| category | Coating, Filling Material, Resin, Class II | Coating, Filling Material, Resin, Class II |
| Trade name | OPTIGLAZE COLOR | G-Coat |
| Manufacturer | GC Corporation | GC Corporation |
| Intended use | For characterization of restorations | |
| made of composite resins & acrylics. | ||
| For obtaining surface smoothness and | ||
| wear resistance of restorations made of | ||
| composite resins & acrylics. | Used to seal the surface of followings to protect | |
| from moisture and dehydration, and to provide | ||
| an extra smooth surface gloss: direct composite | ||
| and glass-ionomer restorations, indirect | ||
| composite restorations, provisional restorations, | ||
| and their adhesive interface of margin to | ||
| enamel or dentin. | ||
| Product | ||
| description | OPTIGLAZE COLOR is a light-cured | |
| glazing and characterizing material for | ||
| such restorations as direct and indirect | ||
| composite resins & acrylics. | G-COAT is a light-cured protective coating | |
| agent to be used to seal the surface of such | ||
| restorations as direct or indirect composites, | ||
| glass-ionomer restorations, provisional and the | ||
| interface between those restorations and | ||
| enamel or dentine. The coated surface | ||
| presents high smoothness, and it may reduce | ||
| or even eliminate the need for manual | ||
| polishing. |
2
| polishing. | ||
|---|---|---|
| Components | Multifunctional acrylate. | |
| Methyl methacrylate. | ||
| Silica filler (amorphous, fumed). | ||
| Photo initiator. | ||
| Pigment. | Multifunctional methacrylate. | |
| Methyl methacrylate. | ||
| Silica filler (amorphous, fumed). | ||
| Photo initiator. | ||
| Instructions for | ||
| use | 1) After contouring the resin surface, | |
| finish with a carbide bur or coarse | ||
| silicone point. |
- Wash and dry the surface.
- Apply a thin layer to the resin surface
using the brush provided. - Light cure with LaboLight LV-3 or
equivalent halogen light for 5 minutes. | a) Contour restoration according to the
manufacturer's instructions.
b) Clean the restoration and adjacent surfaces
to be coated with pumice and water.
c) Rinse and dry.
d) Using a cotton pellet or brush apply G-COA
to all exposed restoration and adjacent surface
e) Light cure for 20 seconds using suitable
visible light curing device.
f) Close bottle immediately after use. |
:
.
:
and the control of the county of the county of
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
GC AMERICA INCORPORATED Dr. Mark Heiss, D.D.S. 3737 W. 127th Street Alsip, IL 60803
Re: K133836
Trade/Device Name: OPTIGLAZE COLOR Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material For Resin Fillings Regulatory Class: II Product Code: EBD Dated: December 13, 2013 Received: December 18, 2013
Dear Dr. Heiss:
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.
4
Page 2 -- Dr. Heiss
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 - Indications for Use Statement
Indications for Use
135836 510(k) Number (if known):
Device Name: Optiglaze Color
Indications for Use:
-
- For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth.
-
- For obtaining surface smoothness and wear resistance of restorations made of composite. resin, acrylic denture base and artificial acrylic teeth.
Prescription Use _ ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Runner -S -05,00,
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