(11 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a composite filling material, with no mention of AI or ML.
No.
The device is a composite filling material used for dental restorations, not for treating diseases or conditions.
No
Explanation: The device is a composite filling material used for dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a "light-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 use is for "composite filling material for both anterior and posterior applications and is indicated for all carious classes." This describes a material used in the body for restorative purposes, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "light-cured composite resin" with characteristics like handling, strength, and radiopacity. This aligns with a dental filling material.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
EsCom100 is a light curing, radiopaque composite filling material for both anterior and posterior applications and is indicated for all carious classes.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
The EsCom100 is light-cured composite resin which makes it ideal for small cavities in anterior and posterior teeth. It has the characteristics of good handling, high compressive strength, and radiopaque. It has 18 shades: A1. A2. A3. A3.5. A4, B1, B3, C2, C3, D2, D3, AO2,AO3, PA1, PA2, PA3,PA3.5 (yellow).
The EsCom100 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 equivalent in design, function and intended use to the predicate devices.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The EsCom100 has the similar mechanical properties as the predicate device: compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience.
The EsCom100 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): 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
SPIDENT
FEB 2 5 2 201 SPIDENT Co., Ltd.
Room 203 & 312. Korea Industrial Complex, 722. Kojan-dong. Namdong-ku. Incheon. Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: __ December. 22, 2010
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | SPIDENT Co., Ltd. |
| Address | Room 203 & 312, Korea Industrial |
| Complex, 722, Kojan-dong, Namdong-ku, | |
| Incheon, Korea 405-821 | |
| Phone | +82(32)819-4570 |
| Fax | +82(32)819-4572 |
| Contact | J. M. Ahn |
2. Device:
Proprietary Name - EsCom100 Common Name - Dental composite and filling materials Classification Name - Tooth shade resin material
-
- Predicate Device:
ESTELITE SIGMA QUICK, K080940
- Predicate Device:
-
- Classifications Names & Citations: EBF, 872.3690
-
- Description:
The EsCom100 is light-cured composite resin which makes it ideal for small cavities in anterior and posterior teeth. It has the characteristics of good handling, high compressive strength, and radiopaque. It has 18 shades: A1. A2. A3. A3.5. A4, B1, B3, C2, C3, D2, D3, AO2,AO3, PA1, PA2, PA3,PA3.5 (yellow).
The EsCom100 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 equivalent in design, function and intended use to the predicate devices.
1
Image /page/1/Picture/0 description: The image shows the word "SPIDENT" in a stylized font. The letters are black and bold, and they are enclosed in a square bracket-like design. The top and bottom lines of the bracket extend beyond the letters, creating a frame around the word.
SPIDENT Co., Ltd.
Room 203 & 312. Korea Industrial Complex. 722. Kojan-dong. Namdong-ku, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
6. Indication for use:
EsCom100 is a light curing, radiopaque composite filling material for both anterior and posterior applications and is indicated for all carious classes.
7. Review:
The EsCom100 has the similar device characteristics as the predicate device, the ESTELITE SIGMA QUICK; intended use, material, chemical composition, design and use concept are similar.
The EsCom100 has the similar mechanical properties as the predicate device: compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience.
The EsCom100 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 EsCom100 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 EsCom100 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
- SPIDENT Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's logo, which consists of three stylized human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Spident Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526
FEB 2 5 231
Re: K110428
Trade/Device Name: EsCom 100 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 31, 2011 Received: February 14, 2011
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 approvisions 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 (1 Nirs), It may of bagfeel to adalof 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- Mr. Mouser
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 mean mat 1 DA mas made a deters and regulations administered by other Federal agencies. of the Act of ally I ederal statues and reguirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting and ilsting (21 CFR 1 at 607), lace.ing (21 CFR 803); good manufacturing (21 CFR 803); good manufacturing (reporting of medical device related ad reror of the may (QS) regulation (21 CFR Part 820);
1 a for a medical as set forth in the quality systems (QS) regulation (21 CFR 820 practice requirements as occession in wet 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/ucm1115809.htm for a Illig.//WWW.Ida.gov//100utf Driveral Health's (CDRH's) Office of Compianter for Devices in the Center the Center 101 Devilos and ruallorogy is reference to premarket notification" prease note the regulation entired, "The orders and of adverse events under the MDR regulation (21 CFR Part 803), please go to
MDR regulation (21 CFR Fart 009), prease go wo
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Ifth; www.laa.gom:re and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may other butter general informational and Consumer Assistance at its toll-free Division of Sinan Manufacts (101) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
San Rasino
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
4
510(k) Number K)d4af
Device Name: EsCom100
Indication for use:
EsCom100 is a light curing, radiopaque composite filling material for use in anterior and posterior restorations and is indicated for all carious classes.
AND/OR Prescription Usc______________________________________________________________________________________________________________________________________________________________ (Per 21CFR801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
| SPIDENT CO., LTD. | 510(k) Number: K110428 |
|---|---|
| ------------------- | ------------------------ |
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