(162 days)
Not Found
No
The summary describes a temporary dental cement and its physical and chemical properties, with no mention of AI or ML.
No.
The device is a temporary cement used for luting dental prosthetics, which is a restorative function, not a therapeutic one. It does not treat or cure a disease or condition.
No
Explanation: The device is a temporary dental cement used for luting crowns and bridges, which is a restorative function, not a diagnostic one.
No
The device description clearly states it is a temporary cement available in a dual barrel syringe and is a light-curing material, indicating it 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 "luting implant-retained crowns, bridges, inlays, onlay and splints." This describes a material used in the mouth for dental procedures, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a "temporary cement" and "temporary filling materials." These are materials used directly on or in the patient's teeth/implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, 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
EsTemp Implant, EsTemp Clear is a non-eugenol temporary cement for luting implantretained crowns, bridges, inlays, onlay and splints.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Estemp temporary resin cement series consists of EsTemp Implant & EsTemp Clear. Each is designed to be suitable for various applications such as cementing temporary crowns, bridges, inlays and splints. They are available in an automix dual barrel syringe. It is light-curing temporary filling materials
The EsTemp Implant, EsTemp Clear 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)
Testing performed including Chemistry of the setting reaction. Proportion of powder to liquid. Maximum solubility and disintegration, Dimensional Change, Working and setting Time, Bonding Strength, Optimum Film thickness, Conductivity & Amount of heat generated during setting. Compressive Strength use which demonstrated that the EsTemp Implant, EsTemp Clear is equivalent to the predicates in specifications and performance characteristics.
Therefore, it was considered that the subject device was as effective as and performs as good as the predicate device.
In conclusion, it can be said that the effectiveness and performance of the subject device are substantially equivalent to those of the predicate device.
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
§ 872.3275 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
SPIDENT
SPIDENT Co., Ltd. 203&312. Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, 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: November 22, 2013
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | SPIDENT Co., Ltd. |
| Address | 203&312, Korea Industrial Complex, 722, |
| Gojan-Dong, Namdong-Gu, Incheon, Korea | |
| 405-821 | |
| Phone | |
| Fax | +82(32)819-4571 |
| +82(32)819-4572 | |
| Contact | Jemo Ahn |
-
- Device:
Proprietary Name - EsTemp Implant. EsTemp Clear Common Name - Dental Cement Classification Name - Cement, Dental
- Device:
-
- Predicate Device:
Premier Implant Cement, K033309
- Predicate Device:
-
- Classifications Names & Citations: EMA, 872.3275
-
- Description:
Estemp temporary resin cement series consists of EsTemp Implant & EsTemp Clear. Each is designed to be suitable for various applications such as cementing temporary crowns, bridges, inlays and splints. They are available in an automix dual barrel syringe. It is light-curing temporary filling materials
The EsTemp Implant, EsTemp Clear 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 bold, black letters. The letters are enclosed in a square border that is open at the top and bottom. The font is sans-serif and appears to be a logo or brand name. The image is simple and clean, with a focus on the text.
6. Indication for use:
EsTemp Implant, EsTemp Clear is a non-eugenol temporary cement for luting implantretained crowns, bridges, inlays, onlay and splints.
7. Performance
Testing performed including Chemistry of the setting reaction. Proportion of powder to liquid. Maximum solubility and disintegration, Dimensional Change, Working and setting Time, Bonding Strength, Optimum Film thickness, Conductivity & Amount of heat generated during setting. Compressive Strength use which demonstrated that the EsTemp Implant, EsTemp Clear is equivalent to the predicates in specifications and performance characteristics.
Therefore, it was considered that the subject device was as effective as and performs as good as the predicate device.
In conclusion, it can be said that the effectiveness and performance of the subject device are substantially equivalent to those of the predicate device.
8. Biocompatibility
Biocompatibility testing confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum #95-1 entitled Use of International Standards ISO 10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing, and is biocompatible. Accordingly, it was considered that the subject device was substantially equivalent in safety to the predicate device.
| No. | Testing Biocompatibility | Results |
|---|---|---|
| 1 | Cytotoxicity | Pass |
| 2 | Sensitization | Pass |
| 3 | Irritation or Intracutaneous reactivity | Pass |
| 4 | Subacute toxicity | Pass |
| 5 | Genotoxicity | Pass |
9. Review:
EsTemp Implant, EsTemp Clear is the similar device characteristics as the predicate device, the Premier Implant Cement; intended use, material, chemical composition, design and use concept are similar.
EsTemp Implant, EsTemp Clear have the similar mechanical properties as the predicate device; Dimensional Change, Working and setting Time, Solubility, Film thickness and Compressive Strength.
2
EsTemp Implant, EsTemp Clear 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 EsTemp Implant, EsTemp Clear 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 EsTemp Implant, EsTemp Clear is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
-
- 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure embracing a three-pronged shape, possibly representing support or assistance.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2014
SPIDENT Company. Limited. c/o Ms. Lena Pak SPIDENT. USA. Incorporated 2115 Linwood Avenue, 50 Floor Fort Lee, NJ 07024
Re: K134021
Trade/Device Name: EsTemp Implant, EsTemp Clear Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: 872.3275 Product Code: EMA Dated: March 5, 2014 Received: March 7, 2014
Dear Ms. Pak:
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.
4
Page 2 - Ms. Pak
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/ReportalProblem/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,
MarySBohner-S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Submission ~ EsTemp implant, EsTemp Clear
510(k) Number K 134021
Device Name: EsTemp Implant, EsTemp Clear
Indication for use: EsTemp Implant, EsTemp Clear is a non-eugenoi temporary cement for luting implantretained crowns, bridges, inlays, onlay and splints.
AND/OR Over-The-Counter Use _ Y Prescription 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)
Sheena A Green
2014.06.10 08:39:25 -04'00'
0.00023
SPIDENT CO., LTD.