CERASMART

K133824 · GC America, Inc. · EBF · Mar 14, 2014 · Dental

Device Facts

• Record ID: K133824
• Device Name: CERASMART
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Mar 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.

Device Story

CERASMART is a pre-cured composite block designed for milling via CAD/CAM systems (Aadva, CEREC, E4D) to create indirect dental restorations. Used by dental professionals in clinical settings, the device is milled into inlays, onlays, veneers, or full crowns (including implant-supported crowns). The pre-cured material offers a restorative alternative to porcelain blocks. The healthcare provider uses the milled restoration to replace missing or damaged tooth structure, potentially improving patient dental function and aesthetics. The device is available in 33 shades and three block sizes.

Clinical Evidence

Bench testing only. Performance metrics evaluated include flexural strength, water sorption, solubility, and radiopacity.

Technological Characteristics

Pre-cured composite resin block for CAD/CAM milling. Available in 33 shades and 3 sizes (12, 14, 14L). Compatible with Aadva, CEREC, and E4D systems. Shelf life of 5 years.

Indications for Use

Indicated for patients requiring inlays, onlays, veneers, or full crown restorations, including crowns on implants, for anterior or posterior teeth.

Regulatory Classification

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.

Predicate Devices

• LAVA Ultimate (K110131)
• MFP-051 (K123631)
• GRADIA CORE (K082171)

Submission Summary (Full Text)

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K133824

# Section 5 - 510(k) Summary

MAR 1 4 2014

GC

GC AMERICA INC. 3737 WEST 127TH STREET 3000 SIP 11 INOIS 60803 TEL [phone] FAX [phone]

- Submitter Information: 1. GC AMERICA INC.
3737 W. 127th Street Alsip, IL 60803 Contact Person: Mark Heiss, D.D.S. Phone: [phone] [phone] Fax:

Date Prepared: December 12, 2013

- 2. Device Name:

| Proprietary Name: | CERASMART | |
|------------------------|----------------------------|--|
| Classification Name: | Tooth shade resin material | |
| Device Classification: | Class II, 872.3690 | |
| Product Code: | EBF | |

#### 3. Predicate Devices:

| Company | Device | 510(k) No. | Date Cleared |
|-------------------------|---------------|------------|--------------|
| 3M ESPE Dental Products | LAVA Ultimate | K110131 | 1/21/2011 |
| GC America Inc. | MFP-051 | K123631 | 7/23/2013 |
| GC America Inc. | GRADIA CORE | K082171 | 10/30/2008 |

- 4. Description of Device:
CERASMART is a pre-cured composite block for milling CAD/CAM indirect restorations. The milled device is used for the restorations of both anterior and posterior teeth.

- న్. Indications for Use:
The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.

- 6. Technological characteristics:
All the components of the applicant device, CERASMART, have already been used in two of the predicate devices (MFP-051 and GRADIA CORE).

- 7. Substantial equivalence:
Thus, 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.

# Differences:

Compared to 3M Lava Ultimate, Cerasmart has a lower water sorption using ISO 10477. MFP-051 and Gradia Core are not pre-cured. MFP-051 is light cured and Gradia Core is chemical cured.

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- 8. Performance Testing - Bench: Flexural strength/MPa Water Sorption/ug/mm3 Solubility/ ug/mm3 Radiopacity
# PACKAGE

- 1. 3 sizes: 12/ 14/ 14L
- 2. 5 blocks in one package
- 3. Available CAD/CAM system: Aadva/ CEREC /E4D

# SHADE

33 shades

(A1 HT, A2 HT, A3 HT, A3.5 HT, A4 HT, B1 HT, B2 HT, B3 HT, B4 HT, C1 HT, C2 HT, C3 HT, C4 HT, D2 HT, D3 HT, D4 HT, A1 LT, A2 LT, A3 LT, A3.5 LT, A4 LT, B1 LT, B2 LT, B3 LT, B4 LT, C1 LT, C2 LT, C3 LT, C4 LT, D2 LT, D3 LT, D4 LT, BL)

| | Applicant device | | Comparative device | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>category | CAD/CAM restorative | CAD/CAM restorative | Light-cured<br>radiopaque<br>universal<br>composite<br>restorative | Light-cured<br>radiopaque<br>universal<br>composite<br>restorative |
| Trade name | CERASMART | LAVA Ultimate<br>(K110131) | MFP-051<br>(K123631) | GRADIA CORE<br>(K082171) |
| Manufacturer | GC Corporation | 3M ESPE | GC Corporation | GC Corporation |
| Intended use | inlays, onlays,<br>veneers and full<br>crown restorations,<br>including crowns on<br>implants. | inlays, onlays, veneers<br>and full crown<br>restorations, including<br>crowns on implants. | 1. Direct restorative for<br>class 1, 2, 3, 4<br>cavities.<br>2. Direct restorative for<br>wedge-shaped<br>defects and<br>root<br>surface cavities.<br>3. Direct restorative for<br>veneers and<br>diastema closure. | 1. Core build-up.<br>2. Post cementation. |
| Product<br>description | CERASMART is a<br>pre-cured composite<br>block for milling<br>CAD/CAM indirect<br>restorations. The<br>milled device is used<br>for the restorations<br>of both anterior and<br>posterior teeth. | The product is a strong,<br>wear-resistant and highly<br>esthetic mill block that<br>provides a fast and<br>easy-to-use alternative to<br>porcelain blocks for<br>milling CAD/CAM<br>indirect restorations. The<br>material is specially<br>processed to enhance its<br>properties<br>for use in CAD/CAM<br>milling procedures. | MFP-051 is a light<br>cured nano-filled<br>radiopaque composite<br>resin filled in a syringe<br>and unitip. The<br>device is used for the<br>restorations of both<br>anterior and posterior<br>teeth. | GRADIA CORE<br>cartridge is a<br>two-paste (base and<br>catalyst) type,<br>dual-cure composite<br>resin filled in double<br>syringe to provide<br>auto-mixing system.<br>The device is used as<br>composite resin for<br>restoration, post<br>cementation and core<br>build-up. |

Shelf Life: 5 years from date of manufacture

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 14, 2014

GC America, Inc. Mark Heiss. DDS Director - Academic & Regulatory Affairs and Professional Relations 3737 West 127th Street Alsip, IL 60803

Re: K133824 Trade/Device Name: CERASMART

Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF, EBG Dated: December 12, 2013 Received: December 17, 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.

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin I. Keith -S

Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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

510(k) Number (if known):

Device Name: CERASMART_

Indications for Use:

The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Mary S. Runner -S - Drs.nd 2014.03.12 1-04-01 -04-00

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