K Number

Device Name

GC BLUE SILICONE

Manufacturer

GC AMERICA, INC.

Date Cleared

2012-05-10

(79 days)

Product Code

ELW

Regulation Number

872.3660

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K110871, K032289, K041398

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties of a silicone impression material, with no mention of AI or ML.

Therapeutic

No
The device is described as an impression material for fit checks by detecting high spots and pressure points on dental restorations, which is a diagnostic or assessment function, not a therapeutic one.

Diagnostic

Yes

SaMD (Software as a Medical Device)

The device description clearly states it is a 2-part cartridge device containing silicone pastes, indicating it is a physical material, not software.

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 to "detect high spots and pressure points of ceramic crowns, ceramic bridges, ceramic inlays and the occlusal surface" using a silicone impression material. This is a mechanical process for fitting dental prosthetics, not a diagnostic test performed on biological samples in vitro (outside the body).
Device Description: The device is a silicone impression material, which is a physical substance used to create a mold.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information about a patient's health condition.

The device is clearly intended for use in a dental setting for the fitting and adjustment of dental restorations, which falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

ELW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K110871, K032289, K041398

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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.

7. Test Methods

	Property	Standards	Test methods	Requirements
1	Detail
reproduction
(µm)	ISO 4823: 2000(E)
Classification: Light bodied
consistency	Detail reproduction was measured by the detail
reproduction test method in ISO 4823	20µm
2	Elastic
Recovery
(%)	ISO 4823: 2000(E)
Classification: Light bodied
consistency	Elastic recovery was measured by the Elastic
recovery test method in ISO4823	≥96.5
3	Strain in
compression
(%)	ISO 4823: 2000(E)
Classification: Light bodied
consistency	Strain in compression was measured by the
Strain 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

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.

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

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:

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