(78 days)
- 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.
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.
The provided text describes the 510(k) premarket notification for "Optiglaze Color," a light-cured glazing and characterizing material for dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.
Here's an analysis of the provided information relative to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical clinical trial report would. Instead, it lists performance bench tests conducted to confirm conformity to specifications. These are implicit acceptance criteria.
| Acceptance Criteria (Bench Tests) | Reported Device Performance |
|---|---|
| Appearance | Confirmed to required specifications and suitable for intended use. |
| Depth of cure | Confirmed to required specifications and suitable for intended use. |
| Color stability after irradiation | Confirmed to required specifications and suitable for intended use. |
| Surface hardness | Confirmed to required specifications and suitable for intended use. (Noted as "higher" than predicate in differences section) |
| Application characteristics | Confirmed to required specifications and suitable for intended use. |
| Packaging | Confirmed to required specifications and suitable for intended use. |
| Shelf Life (3 years) | Confirmed (implied by shelf life evaluation). |
| Storage Conditions (4-25°C) | Confirmed (implied by shelf life evaluation). |
2. Sample size used for the test set and the data provenance
The document describes bench tests rather than a clinical study with a "test set" of patient data. Therefore, specific sample sizes for a clinical test set are not applicable or provided. The data provenance is laboratory-based testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluations mentioned are performance bench tests of the material properties, not interpretations requiring human expert "ground truth" in the diagnostic sense.
4. Adjudication method for the test set
This information is not applicable for bench tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or reported. This document pertains to a dental coating material, not an AI software/device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical dental material, not an algorithm.
7. The type of ground truth used
For the bench tests, the "ground truth" would be established by standardized testing methodologies and specifications for material properties common in dental material science (e.g., ISO standards for depth of cure, hardness measurements, colorimetry for color stability).
8. The sample size for the training set
This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable.
Summary of the Study and Device Proof:
The submitted information is a 510(k) premarket notification for a dental material. The "study" described is a series of performance bench tests designed to demonstrate that the Optiglaze Color material meets required specifications for a dental glazing and characterizing agent. The core of the submission relies on demonstrating substantial equivalence to existing predicate devices (specifically, G-Coat from GC Corporation).
The document states:
- "It is confirmed that the device conforms to the required specifications and is suitable for its intended use." (Page 2)
- The device complies with all requirements of ISO 10993-1 for biological evaluation.
- The curing mechanism is substantially equivalent to predicate devices, implying similar function, composition, and intended use.
Therefore, the "proof" the device meets acceptance criteria is through successful completion of these internal bench tests (appearance, depth of cure, color stability, surface hardness, application characteristics, packaging, shelf life) and the FDA's determination of substantial equivalence, rather than a clinical trial or algorithm performance study.
{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.
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A MIN OR LAND LE LE SELECT | ANNUAL COLLECT LE LAND---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 20 - 1 - 1 - 1 - 1 - | |
|---|---|---|---|
| IN LAND SER E E E LAND SERVED LAUN------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------FINALERS CLASS CLASS COLLECT CAME CAAND OF CHININGS CHARACT CHARACT COLLEGIAL COLLEGIAL COLLEGION COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT CARD AND. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | C--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- 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.
{1}------------------------------------------------
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 | |
|---|---|---|
| Productcategory | 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 restorationsmade of composite resins & acrylics.For obtaining surface smoothness andwear resistance of restorations made ofcomposite resins & acrylics. | Used to seal the surface of followings to protectfrom moisture and dehydration, and to providean extra smooth surface gloss: direct compositeand glass-ionomer restorations, indirectcomposite restorations, provisional restorations,and their adhesive interface of margin toenamel or dentin. |
| Productdescription | OPTIGLAZE COLOR is a light-curedglazing and characterizing material forsuch restorations as direct and indirectcomposite resins & acrylics. | G-COAT is a light-cured protective coatingagent to be used to seal the surface of suchrestorations as direct or indirect composites,glass-ionomer restorations, provisional and theinterface between those restorations andenamel or dentine. The coated surfacepresents high smoothness, and it may reduceor even eliminate the need for manualpolishing. |
{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 foruse | 1) After contouring the resin surface,finish with a carbide bur or coarsesilicone point.2) Wash and dry the surface.3) Apply a thin layer to the resin surfaceusing the brush provided.4) Light cure with LaboLight LV-3 orequivalent halogen light for 5 minutes. | a) Contour restoration according to themanufacturer's instructions.b) Clean the restoration and adjacent surfacesto be coated with pumice and water.c) Rinse and dry.d) Using a cotton pellet or brush apply G-COAto all exposed restoration and adjacent surfacee) Light cure for 20 seconds using suitablevisible 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,
Page 4.1 of 4.1
§ 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.