(15 days)
Not Found
No
The summary describes a temporary dental filling material and its physical properties, with no mention of AI or ML.
No.
The "Intended Use / Indications for Use" states that it is for "Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay," which describes a dental adhesive, not a device used for therapy.
No
Explanation: The device, EsTemp NE, is described as a light-curing temporary filling material used for cementing temporary and provisional restorations. Its intended use is for treatment (cementation), not for diagnosing a condition or disease.
No
The device description clearly states it is a "light-curing temporary filling material," which is a physical substance, 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 the "Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay." This describes a dental material used in the mouth for a restorative procedure.
- Device Description: The description details a "light-curing temporary filling material" with properties like elasticity and compressive strength, relevant to its use as a dental cement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (in the body) as a dental material.
N/A
Intended Use / Indications for Use
Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
EsTemp NE is light-curing temporary filling materials. It has characteristics of high elasticity and high compressive strength. This elastic consistency assures easy removal from cavity, even in case of undercuts, final treatment of cavity is not necessary. The EsTemp NE is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. They are 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)
EsTemp NE 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 3107.
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.
TempBond NE, K894219
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a logo with the word "SPIDENT" inside a rectangular box. The letters are in a simple, sans-serif font. The box is outlined with a thick black line, and there is a small gap in the top right corner of the box.
SPIDENT Co., Ltd. #312. 151B-6L. NamdongKongDan, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
11/00290
FEB 1 7 2010
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: November 27, 2009
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | SPIDENT Co., Ltd. |
| Address | #312, 151B-6L, NamdongKongDan, |
| Incheon, Korea 405-821 | |
| Phone | |
| Fax | +82(32)819-4570 |
| +82(32)819-4572 | |
| Contact | K. H. Baek |
-
- Device:
Proprietary Name - EsTemp NE Common Name - Dental Cement Classification Name - Cement, Dental
- Device:
-
- Predicate Device: TempBond NE, K894219
-
- Classifications Names & Citations: EMA, 872.3275
-
- Description:
EsTemp NE is light-curing temporary filling materials. It has characteristics of high elasticity and high compressive strength. This elastic consistency assures easy removal from cavity, even in case of undercuts, final treatment of cavity is not necessary.
The EsTemp NE is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. They are 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 word is enclosed in a rectangular box with a break in the top and bottom lines between the "D" and "E". The font is sans-serif and appears to be a custom design. The overall design is simple and clean, with a focus on the word itself.
SPIDENT Co., Ltd. #312, 151B-6L, NamdongKongDan, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
6. Indication for use:
Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay.
7. Review:
EsTemp NE has the similar device characteristics as the predicate device, the TempBond NE; intended use, material, chemical composition, design and use concept are similar.
EsTemp NE have the similar mechanical properties as the predicate device: compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience.
EsTemp NE 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 3107.
Based on the comparison of intended use and technical features, the EsTemp NE is substantially equivalent to the predicate devices.
8. 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 EsTemp NE 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 logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
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 1 7 2010
Re: K100290
Trade/Device Name: EsTemp NE Regulation Number: 21CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 19, 2010 Received: February 2, 2010
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. 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- 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 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/MedicalDeviccs/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
Susan Punney
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
K100290 510(k) Number K _
Device Name: EsTemp NE
Indication for use:
Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay.
Prescription Use (Per 21CFR801 Subpart D) AND/OR 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)
Susan Starr
(Division Sign-Off) Division of Anesthesiology. General Hoapital Infection Control. Dental Devices
510(k) Number: K100290