(5 days)
KD12307
KD12307
No
The summary describes a composite resin material and its mechanical properties, with no mention of AI or ML.
No.
The device is a dental material used for core build-ups, fillings, and as a cement, not for treating a disease or condition in a therapeutic manner.
No
The device description indicates its use for "fabrication of core build-ups & build-up fillings" and as a "semipemanent restorative material." Its intended uses are restorative and structural, not for diagnosing medical conditions.
No
The device description clearly states it is a "dual-cured composite resin," which 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 uses listed for Core it Dual are all related to dental procedures performed directly on or in the patient's mouth (core build-ups, luting, splinting, repairs, bite registration, etc.). IVDs are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The description of Core it Dual as a dual-cured composite resin for core build-ups aligns with a dental restorative material, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of this device being used to diagnose, monitor, or screen for any disease or condition by analyzing biological samples.
Therefore, Core it Dual is a dental material used for treatment and restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The principal use for Core it Dual is as a core material either with adhesives or with pins or posts. Core it Dual can also be used for: Luting of abutments to dentures - Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials - Repair material for provisionals - Bite registration material. - Build up material for plastic bite rails (occlusal individualisation). - Cement for pins and posts - Semipermanent restorative material (e.g., in childrens' teeth)
Product codes
EBF
Device Description
The Core it Dual is a dual-cered composite resin designed for the fabrication of core build-ups & build-up fillings. It has the characteristics of good depth of polymerization, high compressive strength, and radiopaque. It has two shades (Blue, yellow).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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)
The Core it Dual has the similar device characteristics as the predicate device, the Luxa Core Dual; intentied use, material, chemical composition, design and use concept are similar. The Core it Dual has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience. The Core it Dual has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LuxaCore/ LuxaCore Dual, KD12307
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ag 2572
SPIDENT Co., Ltd. 4312, 151B-6L, NamdosgKongDan, Inchesn, Korea 405-821 Tel: +82(32)8 19-4570 Fax : +82(32)3 19-4572
510(k) Summary
This summary of 5 00(k) salety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(ci.
Date: July 22, 2009
- Company and Correspondent making the submission
AUG 2 6 2009
| Company | |
|---|---|
| Name | SPIDENT Co., Ltd. |
| Address | #312, 151B-6L, NamdongKongDan, |
| Incheon, Korea 405-821 | |
| Phone | +82(32)819-4570 |
| Fax | +82(32)819-4572 |
| Contact | I. S. Whang |
- Device:
Proprietary Name - Core · it Dual Common Name - Core Build ep Resin Classification Name - Tooth shade resin material
-
- Predicate Device:
LuxaCore/ LuxaCore Dual, KD12307
- Predicate Device:
-
- Classifications Names & Citations: EBF, 872.3690
-
- Description:
The Core it Dual is a dual-cered composite resin designed for the fabrication of core build-ups & build-up fillings. It has the characteristics of good depth of polymerization, high compressive strength, and radiopaque. It has two shades (Blue, yellow).
The Core it Dual is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially cquivalent in design, function and intended use to the predicate devices.
021
1
Image /page/1/Picture/0 description: The image shows a logo with the word "SPIDENT" inside a square. The letters are in a bold, sans-serif font and appear to be slightly distressed or textured. The square border around the word is also thick and has a similar distressed appearance, giving the logo a somewhat vintage or worn look.
SPIDENT Co., Ltd.
#312, 151B-6L, NamstongRongDun, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
- Indication for use:
The principal use for Core it Dual is as a core material cither with adhesives or with pins or posts. R
Core it Dual can also be used for:
· Luting of abutments to dentures
- · Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
- · Repair material for provisionals
- · Bite registration material.
- · Build up matcrial for plastic bite rails (occlusal individualisation).
- · Cement for pins and posts
- · Semipermanent restorative material (e.g., in childrens' tecth)
7. Review:
The Core it Dual has the similar device characteristics as the predicate device, the Luxa Core Dual; intentied use, material, chemical composition, design and use concept are similar.
The Core it Dual has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience.
The Core it Dual has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049.
Based on the comparison of intended use and technical features, the Core it Dual is substantially equivalent to the predicate devices.
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's "Guidance for the Preparation of Premarket notifications for Dental Composite" and based on the information provided in this premarket notification. SPIDENT Co., Ltd. concludes that the Core it Dual is safe and effective and substantially equivalent to predicate devices as described herein.
- SPIDENT Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END
022
2
Image /page/2/Picture/1 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 an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Spident Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated Laboratory and Testing 2600 NW Lake Road Camas, Washington 98607-9526
Re: K092572
Trade/Device Name: Core it Dual Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 29, 2009 Received: August 21, 2009
Dear Mr. Mouser:
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.
AUG 2 6 2009
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
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/Reporta Problem/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,
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number K 092572
Device Name: Core it Dual
Indication for use:
The principal use for Core it Dual is as a core material either with adhesives or with pins or posts.
Corc+it Dual can also be used for:
Luting of abutments to dentures i
-
Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials 높
Repair material for provisionals -
Bite registration material.
-
Build up material for plastic bite rails (occlusal individualisation).
-
Cement for pins and posts
-
Semipennanent restorative material (e.g., in childrens teeth)
Prescription Use AND/OR Over-The-Counter Use (Per 21CFR807 Subpart C) (Per 21CFR801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
SPIDENT CO., LTD.
Ren Mely for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K092572
020