(73 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a dental resin, with no mention of AI or ML.
No
This device is a temporary dental material, not a therapeutic device. It is used to temporarily restore teeth before a permanent restoration.
No
This device is described as a self-curing temporary crown resin for temporary use before permanent restoration. Its function is to provide a temporary dental prosthetic, not to identify or diagnose a disease or condition. The performance metrics listed are related to material properties (e.g., strength, color, shrinkage), not diagnostic accuracy.
No
The device description clearly states it is a "temporary crown and bridge resin," which is a physical material, not software. The performance studies also focus on material properties like strength, solubility, and color, further indicating it is a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that Hexa-Temp is a "self-curing temporary crown resin that is used temporarily before repairing a permanent restoration." This is a material used in the mouth, directly on the tooth, for a restorative purpose. It is not used to analyze a specimen from the body.
- Anatomical Site: The anatomical site is "Tooth," which is a part of the body, not a specimen taken from the body for analysis.
The information provided describes a dental material used for temporary restorations, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Self-curing temporary crown resin that is used temporarily before repairing a permanent restoration
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength. Various shades of TW, A1, A2, A3, B1, C2, AO3 and BL for esthetic crown are provided. Hexa-Temp contains about 38% inorganic filler. Inorganic filler has a size of 16nm ~ 3.22µm.
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
Dentist
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 performance test was conducted to prove the substantially equivalence of the subject device, and the standards applied to the performance test are as follows.
- ISO 10477:2018, Dentistry Polymer-based crown and veneering materials.
Biocompatibility tests and biological safety evaluation were performed and the results proved that the subject device is at least as biocompatible and biologically safe as the predicate device.
The standards applied are as follows. - ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ISO 10993-3:2014, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-6:2016, Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- ISO 10993-10:2010, Biological evaluation of medical devices. Tests for irritation and skin sensitization
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-18:2020, Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
- ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
•Water sorption (µg/mm³): 24.89
•Solubility (µg/mm³): 3.85
•Color and color consistency: There is Color consistency and Color stability.
•Polymerization Temperature: Did not exceed 45°C
•Polymerization Shrinkage (%): 2.63
•Compressive Strength (MPa): 330.38
•Flexural Strength (MPa): 69.93
•Surface finish: It's smooth and glossy.
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
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 10, 2022
Spident Co., Ltd. J.M. Ahn President 203 & 312, Korea Industrial Complex, 722 Gojan-Dong, Namdong-Gu, Incheon 405-821 Korea, South
Re: K214071
Trade/Device Name: Hexa-Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: December 21, 2021 Received: December 27, 2021
Dear J.M. Ahn:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214071
Device Name Hexa-Temp
Indications for Use (Describe)
Self-curing temporary crown resin that is used temporarily before repairing a permanent restoration
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for SPIDENT. The logo is green and features the word "SPIDENT" in a sans-serif font. The letters are all capitalized and are a bright green color. The logo is enclosed in a green box that is open on the top and left sides.
SPIDENT CO., LTD.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82-32-821-0071 Fax : +82-32-821-0074
Section 5. 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 21, 2021
-
- 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 Tel : +82-32-821-0071 Fax : + 82-32-821-0074 Company Contact : J.M. Ahn / President
2. Device Name and Classification
Proprietary Name : Hexa-Temp Common name : Temporary crown and bridge resin Classification name : Temporary crown and bridge resin [CFR 872.3770] Product code : EBG Class : II
3. Predicate Devices (Legally Marketed Devices)
The predicate devices for Hexa-Temp is :
- · STRUCTUR 2 SC, VOCO GMBH, K040769
4. Description:
Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength. Various shades of TW, A1, A2, A3, B1, C2, AO3 and BL for esthetic crown are provided. Hexa-Temp contains about 38% inorganic filler. Inorganic filler has a size of 16nm ~ 3.22µm.
5. Indications for Use
Self-curing temporary crown resin that is used temporarily before repairing a permanent restoration
4
Image /page/4/Picture/0 description: The image is a logo for SPIDENT. The logo is green and features the word "SPIDENT" in a sans-serif font. The word is enclosed in a square with a break in the upper left corner. The logo is simple and modern.
6. Performance Testing - Bench
The performance test was conducted to prove the substantially equivalence of the subject device, and the standards applied to the performance test are as follows.
- · ISO 10477:2018, Dentistry Polymer-based crown and veneering materials.
7. Biocompatibility
Biocompatibility tests and biological safety evaluation were performed and the results proved that the subject device is at least as biocompatible and biologically safe as the predicate device.
The standards applied are as follows.
- · ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- · ISO 10993-3:2014, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- · ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- · ISO 10993-6:2016, Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- · ISO 10993-10:2010, Biological evaluation of medical devices. Tests for irritation and skin sensitization
- · ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- · ISO 10993-18:2020, Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
- · ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
| Product Name | Hexa-Temp | Structur 2 SC |
|---|---|---|
| 510(k) | N/A | K040769 |
| Manufacturer | SPIDENT CO., LTD. | VOCO GMBH |
| Product | ||
| description | Hexa-Temp is temporary crown and | |
| bridge resin that is used temporarily | ||
| before repairing a permanent | ||
| restoration. It can be self-cured | ||
| resin. Filler size ranges from 0.7 to | ||
| 1.2 µm, resulting in good radio- | ||
| opacity and high flexural strength. | ||
| Various shades of TW, A1, A2, A3, | ||
| B1, C2, AO3 and BL for esthetic | ||
| crown are provided. Hexa-Temp | ||
| contains about 38% inorganic filler. | ||
| Inorganic filler has a size of 16nm | ||
| ~ 3.22µm. | Structur 2 SC is a fluorescent self- | |
| curing paste-paste system for the | ||
| production of temporary crowns, | ||
| bridges, inlays and onlays. Structur | ||
| 2 SC consists of base paste and | ||
| catalyst paste. | ||
| Chemical | ||
| composition of | ||
| Resin | Methacrylate matrix(Bis-GMA, | |
| TEGDMA) | Methacrylates, amines, terpenes, | |
| benzoyl peroxide and BHT | ||
| Indications for use | Self-curing temporary crown resin | |
| that is used temporarily before | ||
| repairing a permanent restoration | Structur 2SC is indicated for the | |
| fabrication of temporary crowns, | ||
| bridges, inlays and onlays. | ||
| Principle of | ||
| operation | Self-cured | Self-cured |
| Mechanical | ||
| Properties | ||
| •Water sorption | ||
| (µg/mm³) | 24.89 | 14.59 |
| •Solubility | ||
| (µg/mm³) | 3.85 | 3.15 |
| •Color and color | ||
| consistency | There is Color consistency and | |
| Color stability. | There is Color consistency and | |
| Color stability. | ||
| •Polymerization | ||
| Temperature | Did not exceed 45°C | Did not exceed 45°C |
| •Polymerization | ||
| Shrinkage (%) | 2.63 | 2.50 |
| •Compressive | ||
| Strength | ||
| (MPa) | 330.38 | 294.82 |
| •Flexural Strength | ||
| (MPa) | 69.93 | 86.42 |
| •Surface finish | It's smooth and glossy. | It's smooth and glossy. |
| Standard | ||
| conformed | ISO 10477 | ISO 10477 |
| Biocompatibility | Yes | Yes |
| Application Area | Tooth | Tooth |
| Target Population | Dental patient | Dental patient |
| Intended | ||
| Operator | Dentist | Dentist |
| Storage condition | 2-27°C | 4-23°C |
| Shade | TW, A1, A2, A3, B1, C2, AO3 and | |
| BL | A1, A2, A3, A3.5, B1, B3, C2 and | |
| BL |
8. Substantial Equivalence Discussion
5
Image /page/5/Picture/0 description: The image shows the logo for Spident. The logo is green and features the word "SPIDENT" in a sans-serif font. The letters are enclosed in a square border that is open at the top and bottom. The logo is simple and modern.
SPIDENT CO., LTD.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82-32-821-0071 Fax : +82-32-821-0074
6
Image /page/6/Picture/0 description: The image shows the word "SPIDENT" in green font. The word is partially enclosed in a green square. The square is open on the top and left sides, and the word is positioned inside the square.
SPIDENT CO., LTD.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82-32-821-0071 Fax : +82-32-821-0074
9. Similarities and Differences with Marketed Devices:
The subject device, Hexa-Temp and the predicate device, Structur 2 SC was compared as above. Both products have the similar product description as a temporary crown and bridge resin.
In case of composition, two products contain slightly different raw materials, but the subject device and the predicate device show the same performance as methacrylic monomer and inhibitor, initiator, pigment, filler. Filler information of predicate device is unknown, but it will be similar as the general characteristics of the temporary crown and bridge resin.
Indication for use of the two products are almost same and both products can be used as self-cure.
As the mechanical properties, clinically important items of the temporary crown resin were selected: Water sorption, Solubility, Color and Color stability, Polymerization temperature, Polymerization shrinkage, Compressive strength, and Flexural strength. Among them,
Water sorption, Solubility, Color and Color stability, and Flexural strength belong to ISO 10477 items.
The performance results of the two products are not the same, but both products meet the requirements of ISO 10477 and it can be seen that the main clinical performance is comparable or superior.
For this reason, despite difference in material, both the subject device and the equivalent device have no problem in terms of the clinical performance.
Biocompatibility, Application Area, Target Population, Intended Operator of both products are the same.
7
Image /page/7/Picture/0 description: The image shows the logo for SPIDENT. The logo is green and features the word "SPIDENT" in a sans-serif font. The letters are enclosed in a square with a break in the upper left corner. The logo is simple and modern.
SPIDENT CO., LTD. 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82-32-821-0071 Fax : +82-32-821-0074
In case of Storage condition and Shade, there is a slight difference but performance and biocompatibility test showed that these differences would not raise any new questions of safety and effectiveness. Therefore, Hexa-Temp is substantially equivalent with predicate device, Structur 2 SC, and at least as safe and effective as the predicate device.
10. Conclusion
Based on a comparison of subject device, Hexa-Temp (SPIDENT CO., LTD) and predicate device, Structur 2 SC (VOCO GMBH), it is confirmed that the subject device is substantially equivalent to predicate device.