(269 days)
Resin for Temporary Crown & Bridge is indication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.
The Resin for Temporary Crown & Bridge is made by Methacrylate Oligomer based on the Urethane Acrylate Oligomer with 0.01~0.1wt% inorganic filler. It has stored in a brown 1000ml of HDPE bottle. It contains materials with colors of A2 based on the shade guide. This Product is a liquid photo-curable material that is polymerized by UV laser at 405nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 0.1 to 0.010mm in thickness, and is output at a resolution of 0.1 to 0.03 mm on the x, y axis. This device should use ZENITH 3D Printer equipment using UV light source of Dentis Co., Ltd., and it is possible to produce three dimensional printed matter by curing lamination step by step a thicknesses of 100, 50 and 16um.
The provided text is a 510(k) Summary for a medical device called "Resin for Temporary Crown & Bridge." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the device itself.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance data. Instead, it mentions that "Performance testing confirmed the Resin for Temporary Crown & Bridge demonstrated equivalent or better performance to the predicate device or acceptance criteria referred to ISO 10477." This implies that ISO 10477 serves as the acceptance criteria for certain performance aspects, and the device met or exceeded them without providing specific values.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but the testing was "non-clinical testing" conducted to validate the product against the company's specified design requirement.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The study conducted was non-clinical testing focused on material properties and biocompatibility, not human interpretation or diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable. There was no human interpretation involved in establishing ground truth for this type of non-clinical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a material for dental restorations, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used:
For the non-clinical testing, the "ground truth" was established by standards and internal company specifications. Specifically:
- Biocompatibility was evaluated based on ISO 10993-3, EN ISO 10993-5, EN ISO 10993-10 and EN ISO 10993-11.
- Performance specifications (e.g., compressive & tensile loads, hardness, water sorption, solubility) were compared to the predicate device or acceptance criteria referred to ISO 10477.
8. The sample size for the training set:
Not applicable. This device is a material, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
{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.
December 7, 2018
Dentis Co., Ltd. % Hwi Joon Park Consultant Allura Medical Solution Inc. 8141 Lampson Ave. #4 Garden Grove, California 92841
Re: K180657
Trade/Device Name: Resin for Temporary Crown & Bridge Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: September 13, 2018 Received: September 14, 2018
Dear Hwi Joon Park:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Figure/5 description: The image shows a digital signature. The signature is from Mary S. Runner -S3. The date of the signature is 2018.12.07, and the time is 10:21:47 -05'00'.
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K180657
Device Name Resin for Temporary Crown & Bridge
Indications for Use (Describe)
Resin for Temporary Crown & Bridge is indication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.
| 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}------------------------------------------------
510(k) Summary K180657
| Submitter | Dentis Co., Ltd.99, Seongseoseo-ro, Dalseo-gu, Daegu, 42718 Republic of KoreaPhone. +82-53-583-2804Fax. +82-53-283-2806 |
|---|---|
| Contact Person | HWI JOON PARK8141 Lampson Ave. #4, Garden Grove, CA 92841, USAPhone: +1-972-800-0044Fax: +1-210-899-0079 |
| Submission Date | Mar 08, 2018 |
| Trade / Proprietaryname | Resin for Temporary Crown & Bridge |
| Common / UsualName | Crown and Bridge, Temporary, Resin |
| Classification NameClassification CodeRegulatory ClassRegulation Number | Temporary Crown and Bridge ResinEBGClass II 872.3770 |
| Predicate Device | DeltaMed GMBHe-Dent Temporary Resin and Extra-Oral Curing System(K102776, Feb 18, 2011 - Primary Predicate) |
| Description ofDevice | The Resin for Temporary Crown & Bridge is made by MethacrylateOligomer based on the Urethane Acrylate Oligomer with 0.01~0.1wt%inorganic filler. It has stored in a brown 1000ml of HDPE bottle. It containsmaterials with colors of A2 based on the shade guide.This Product is a liquid photo-curable material that is polymerized by UV laserat 405nm. It can be used to make a tooth model with a photo-curable polymerthat is cured by ultraviolet light. The liquid UV curing resin is cured at aspecific wavelength (405nm) by the photo-initiator contained in the resin.Curing in a 3D printer is related to the conditions of the printer equipment, andis typically 0.1 to 0.010mm in thickness, and is output at a resolution of 0.1 to0.03 mm on the x, y axis. This device should use ZENITH 3D Printerequipment using UV light source of Dentis Co., Ltd., and it is possible toproduce three dimensional printed matter by curing lamination step by step athicknesses of 100, 50 and 16um. |
| Indication for Use | Resin for Temporary Crown & Bridge is indicated for the fabrication oftemporary dental restorations in conjunction with extra-oral curing lightequipment. Duration is less than 30 days in oral environment. |
| Comparison ofTechnologicalCharacteristics withthe Predicate Devices | Indication for UseThe Resin for Temporary Crown & Bridge and the predicate device havesimilar indications for use statements. Limitation on the duration of thesubject device was intended to ensure the performance of subject device bynarrowing down the allowed terms of its prosthetic use. Such difference isnot critical to the intended use of the subject device.Therefore it doesn't affect the safety and effectiveness of the device whenused as labeled. |
| Technological CharacteristicsThe subject device is a polymer that changes its properties when exposedto UV light. It conforms into a hardened polymeric material through aprocess called curing. Temporary dental restoration using resin istechnologically useful applications for dental treatment. | |
| Above technological characteristics of the subject device is identical tothe predicate device. | |
| MaterialsThe subject device is composed of the each raw material whose safety wereevaluated by suppliers and the results were indicated on MSDS. Moreover,the Resin for Temporary Crown & Bridge was evaluated for biocompatibilitybased on ISO 10993. | |
| Clinical TestsThe Resin for Temporary Crown & Bridge and the cited predicate device werenot conducted clinical tests to determine substantial equivalence. | |
| Non-clinical TestsNon-clinical testing was performed in order to validate the product againstthe company's specified design requirement.The Resin for Temporary Crown & Bridge in all variants were tested withrespect to biocompatibility according to EN ISO 10993-3, EN ISO 10993-5,EN ISO 10993-10 and EN ISO 10993-11. The laboratory certified that theinsolubility is in compliance with the requirements of the standard. There isno evidence that effects hazardous to the patient will arise by leachableingredients/contaminants.The composition of the Resin for Temporary Crown & Bridge exhibitssufficient strengths and performances in all intraoral conditions and willsufficiently resist compressive & tensile loads, hardness, water sorption andsolubility. | |
| SterilizationThe Resin for Temporary Crown & Bridge and the cited predicate device areprovided non-sterile. | |
| Performance SpecificationPerformance testing confirmed the Resin for Temporary Crown & Bridgedemonstrated equivalent or better performance to the predicate device oracceptance criteria referred to ISO 10477. | |
| Conclusion | It is adequate for the intended use and it shows that there are nosignificant differences between the Resin for Temporary Crown &Bridge and the predicate device currently being marketed that wouldadversely affect the use of the product. Any differences intechnological characteristics do not raise new issues of safety orefficacy.Therefore, conclusions drawn from testing demonstrate that theResin for Temporary Crown & Bridge is substantially equivalent in performance to predicate device. |
{4}------------------------------------------------
§ 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.