(87 days)
Not Found
No
The summary describes a pre-cured composite block for milling, with performance studies focused on material properties. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making.
No
The device is a pre-cured composite block used for milling dental restorations, which are used to replace or restore tooth structure, not to treat or cure a disease or medical condition.
No
Explanation: The device is described as a pre-cured composite block for milling indirect restorations for teeth. Its intended use is for actual restorative procedures (inlays, onlays, veneers, full crown restorations), not for diagnosing conditions.
No
The device description clearly states it is a "pre-cured composite block for milling CAD/CAM indirect restorations," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations (inlays, onlays, veneers, crowns) for teeth. This is a direct treatment or restoration of a physical structure within the body.
- Device Description: The device is a pre-cured composite block for milling. This is a material used to fabricate a medical device (the restoration).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a dental material used to create a dental prosthesis or restoration, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Flexural strength/MPa Water Sorption/ug/mm3 Solubility/ ug/mm3 Radiopacity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.
0
Section 5 - 510(k) Summary
MAR 1 4 2014
GC
GC AMERICA INC. 3737 WEST 127TH STREET 3000 SIP 11 INOIS 60803 TEL (708) 597-0900 FAX (708) 371-5103
- Submitter Information: 1. GC AMERICA INC.
3737 W. 127th Street Alsip, IL 60803 Contact Person: Mark Heiss, D.D.S. Phone: (708) 926-3090 (708) 926-9100 Fax:
Date Prepared: December 12, 2013
-
- 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 |
-
- 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.
- Description of Device:
-
న్. Indications for Use:
The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants. -
- 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).
- Technological characteristics:
-
- 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.
- Substantial equivalence:
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.
Page 5.1 of 5.2
1
-
- Performance Testing - Bench: Flexural strength/MPa Water Sorption/ug/mm3 Solubility/ ug/mm3 Radiopacity
PACKAGE
-
- 3 sizes: 12/ 14/ 14L
-
- 5 blocks in one package
-
- 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 | ||||
| category | CAD/CAM restorative | CAD/CAM restorative | Light-cured | |
| radiopaque | ||||
| universal | ||||
| composite | ||||
| restorative | Light-cured | |||
| radiopaque | ||||
| universal | ||||
| composite | ||||
| restorative | ||||
| Trade name | CERASMART | LAVA Ultimate | ||
| (K110131) | MFP-051 | |||
| (K123631) | GRADIA CORE | |||
| (K082171) | ||||
| Manufacturer | GC Corporation | 3M ESPE | GC Corporation | GC Corporation |
| Intended use | inlays, onlays, | |||
| veneers and full | ||||
| crown restorations, | ||||
| including crowns on | ||||
| implants. | inlays, onlays, veneers | |||
| and full crown | ||||
| restorations, including | ||||
| crowns on implants. | 1. Direct restorative for | |||
| class 1, 2, 3, 4 | ||||
| cavities. |
- Direct restorative for
wedge-shaped
defects and
root
surface cavities. - Direct restorative for
veneers and
diastema closure. | 1. Core build-up. - Post cementation. |
| Product
description | 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. | The product is a strong,
wear-resistant and highly
esthetic mill block that
provides a fast and
easy-to-use alternative to
porcelain blocks for
milling CAD/CAM
indirect restorations. The
material is specially
processed to enhance its
properties
for use in CAD/CAM
milling procedures. | MFP-051 is a light
cured nano-filled
radiopaque composite
resin filled in a syringe
and unitip. The
device is used for the
restorations of both
anterior and posterior
teeth. | GRADIA CORE
cartridge is a
two-paste (base and
catalyst) type,
dual-cure composite
resin filled in double
syringe to provide
auto-mixing system.
The device is used as
composite resin for
restoration, post
cementation and core
build-up. |
Shelf Life: 5 years from date of manufacture
Page 5.2 of 5.2
2
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.
3
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/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
4
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
Page 4.1 of 4.1