GC BLUE SILICONE is a silicone impression material for fit check by detecting the high spots and pressure points of ceramic crowns, ceramic bridges, ceramic inlays and the occlusal surface.

Device Description

GC BLUE SILICONE is available in a 2-part cartridge device in which part 1 is a base silicone paste and part 2 is a catalyst silicone.

AI/ML Overview

The provided text is a 510(k) summary for a dental impression material named "GC BLUE SILICONE." It outlines the device description, indications for use, predicate devices, and performance testing based on ISO standards. However, it does not describe:

An AI/Software as a Medical Device (SaMD) device.
Any study involving a test set, training set, or concepts like ground truth, expert readers, or multi-reader multi-case (MRMC) studies.
Acceptance criteria related to AI model performance metrics (e.g., sensitivity, specificity, AUC).

Instead, the acceptance criteria and performance data are related to physical properties of the dental impression material, measured according to ISO standards.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the content of this 510(k) summary for a physical medical device.

Here's the information that can be extracted from the document, tailored to the testing of a physical material:

The device, GC BLUE SILICONE, is a silicone impression material. Its performance was evaluated against specific physical properties as outlined by ISO 4823:2000(E) standards for dental impression materials.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides the acceptance criteria (requirements) for three key properties based on ISO 4823:2000(E) for "Light-bodied consistency." It does not explicitly state the reported device performance results in this summary, only the requirements it must meet.

Property	Standards	Acceptance Criteria (Requirements)	Reported Device Performance
Detail reproduction (µm)	ISO 4823: 2000(E) Classification: Light bodied consistency	20µm	Not explicitly reported
Elastic Recovery (%)	ISO 4823: 2000(E) Classification: Light bodied consistency	≥96.5	Not explicitly reported
Strain in compression (%)	ISO 4823: 2000(E) Classification: Light bodied consistency	2.0-20	Not explicitly reported

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in this 510(k) summary. Testing for physical properties like these typically involves a specific number of samples for each test, as defined by the ISO standard.
Data Provenance: The tests were conducted according to international standards (ISO 4823:2000(E)). The document implies the tests were performed by GC America Inc. or a contracted lab. There is no mention of country of origin of data or retrospective/prospective study design as these concepts apply more to clinical or AI data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for physical material properties is established by adherence to measurement protocols specified in recognized international standards (ISO 4823:2000(E)), not by expert consensus or review.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for subjective medical image interpretation or clinical outcomes, not for objective physical property measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not applicable. This is a physical material, not an AI or imaging device requiring human-in-the-loop studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical material, not an algorithm.

7. The type of ground truth used:

The "ground truth" (or reference standard) for these tests is defined by the measurement methodology and acceptance criteria specified in the ISO 4823:2000(E) standard. These are objective, quantitative measurements of material properties.

8. The sample size for the training set:

Not applicable. This device is a physical material, not a machine learning model; therefore, no "training set" is involved.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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K120521.

Image /page/0/Picture/1 description: The image shows the letters 'GCI' in a bold, sans-serif font. The letters are black and the background is white. There are quotation marks on either side of the letters.

MAY 1 0 2012

GC AMERICA INC. 3737 WEST 127TH STREET ALSIP. ILLINOIS 60803 TEL (708) 597-0900 FAX (708) 371-5103

Section 5 - 510(k) Summary

1. Submitter Information:
  GC AMERICA INC.
  3737 W. 127" Street Alsip, IL 60803

Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 926-3090
Fax:	(708) 597-6222

Date Prepared: February 17, 2012

1. Device Name:

Proprietary Name:	GC BLUE SILICONE
Classification Name:	Dental Impression material
Device Classification:	872.3660
Product Code:	ELW

1. Predicate Devices:

Product	Applicant	510(k) No.	Code No
Fit Checker Advanced	GC AMERICA, INC	K110871	ELW
Fit Checker II	GC AMERICA, INC	K032289	ELW
GC Fusion (EXA'lence)	GC AMERICA, INC	K041398	ELW

4. Description of Device:

GC BLUE SILICONE is available in a 2-part cartridge device in which part 1 is a base silicone paste and part 2 is a catalyst silicone.

5. Indications for Use:

GC BLUE SILICONE is a silicone impression material for fit check by detecting the high spots and pressure points of ceramic crowns, ceramic bridges, ceramic inlays and the occlusal surface.

1. Description of Safety and Substantial Equivalence:
  The applicant device, GC BLUE SILICONE is equivalent to predicate device, Fit Checker II, in its intended use. The applicant device, GC BLUE SILICONE, is equivalent to the predicate device, Fit Checker Advanced and GC Fusion (EXA'lence) in its chemical compositions.

Image /page/0/Picture/19 description: The image contains two logos. The logo on the left is a diamond shape with text inside that reads "CHECKED TO AS 14181 BY POWER SAFE". The logo on the right has the letters "DTA" stacked vertically with the word "MEMBER" above it.

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7. Test Methods

	Property	Standards	Test methods	Requirements
1	Detailreproduction(µm)	ISO 4823: 2000(E)Classification: Light bodiedconsistency	Detail reproduction was measured by the detailreproduction test method in ISO 4823	20µm
2	ElasticRecovery(%)	ISO 4823: 2000(E)Classification: Light bodiedconsistency	Elastic recovery was measured by the Elasticrecovery test method in ISO4823	≥96.5
3	Strain incompression(%)	ISO 4823: 2000(E)Classification: Light bodiedconsistency	Strain in compression was measured by theStrain in compression test method in ISO 4823	2.0-20

Test standards and methods based on ISO standards

1. Shelf Life Evaluation and Storage Conditions:
Shelf Life 2 years -
Store in a cool and dark place. 15-25°C (60-77.0°F) -
1. Packaging

Two cartridge package :

Cartridge 62g (48mL) x 1, Mixing Tip II S x 2 Mixing Tip II SS x 2

Optional

· 1. CARTRIDGE DISPENSER II
- 2. MIXING TIP II SS Refill Package

Accessories necessary for proper functioning of the device: Mixing tip II S

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mark Heiss, DDS Director - New Business Development, Academic and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

MAY 1 0 2012

Re: K120521

Trade/Device Name: GC Blue Silicone Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: February 17, 2012 Received: February 21, 2012

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.

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

Indications for Use

12052 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________ GC BLUE SILICONE

Indications for Use:

GC BLUE SILICONE is a silicone impression material for fit check by detecting the high spots and pressure points of ceramic crowns, ceramic bridges, ceramic inlays and the occlusal surface.

Prescription Use __ X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Page 4.

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 4.1 of 4.1

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).