(269 days)
Not Found
No
The device description and testing focus solely on the material properties and curing process of a dental resin, with no mention of AI or ML algorithms for analysis, prediction, or control.
Yes
The device is described as a "Resin for Temporary Crown & Bridge" used for "temporary dental restorations," which directly relates to treating or restoring a dental condition.
No
The device is a material (resin) for creating temporary dental restorations (crowns and bridges), not for diagnosing conditions. Its purpose is to physically replace or repair teeth.
No
The device description clearly states it is a resin material used for temporary dental restorations and is cured by UV light, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is a resin used to create temporary dental restorations (crowns and bridges) that are placed in the oral environment. It is a material used to construct a physical device for direct patient use.
- Intended Use: The intended use is for temporary dental restorations, not for testing biological samples.
- Device Description: The description focuses on the chemical composition of the resin and how it is cured to form a physical object.
- Testing: The testing described is related to the biocompatibility and physical properties of the material for use in the mouth, not diagnostic performance on biological samples.
Therefore, this device falls under the category of a dental material used for restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
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.
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)
Non-clinical testing was performed in order to validate the product against the company's specified design requirement. The Resin for Temporary Crown & Bridge in all variants were tested with respect 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 the insolubility is in compliance with the requirements of the standard. There is no evidence that effects hazardous to the patient will arise by leachable ingredients/contaminants. The composition of the Resin for Temporary Crown & Bridge exhibits sufficient strengths and performances in all intraoral conditions and will sufficiently resist compressive & tensile loads, hardness, water sorption and solubility. 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.
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
§ 872.3770 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.
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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
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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) |
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510(k) Summary K180657
| Submitter | Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, 42718 Republic of Korea
Phone. +82-53-583-2804
Fax. +82-53-283-2806 |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | HWI JOON PARK
8141 Lampson Ave. #4, Garden Grove, CA 92841, USA
Phone: +1-972-800-0044
Fax: +1-210-899-0079 |
| Submission Date | Mar 08, 2018 |
| Trade / Proprietary
name | Resin for Temporary Crown & Bridge |
| Common / Usual
Name | Crown and Bridge, Temporary, Resin |
| Classification Name
Classification Code
Regulatory Class
Regulation Number | Temporary Crown and Bridge Resin
EBG
Class II 872.3770 |
| Predicate Device | DeltaMed GMBH
e-Dent Temporary Resin and Extra-Oral Curing System
(K102776, Feb 18, 2011 - Primary Predicate) |
| Description of
Device | 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. |
| Indication for Use | Resin for Temporary Crown & Bridge is indicated for the fabrication of
temporary dental restorations in conjunction with extra-oral curing light
equipment. Duration is less than 30 days in oral environment. |
| Comparison of
Technological
Characteristics with
the Predicate Devices | Indication for Use
The Resin for Temporary Crown & Bridge and the predicate device have
similar indications for use statements. Limitation on the duration of the
subject device was intended to ensure the performance of subject device by
narrowing down the allowed terms of its prosthetic use. Such difference is
not critical to the intended use of the subject device.
Therefore it doesn't affect the safety and effectiveness of the device when
used as labeled. |
| | Technological Characteristics
The subject device is a polymer that changes its properties when exposed
to UV light. It conforms into a hardened polymeric material through a
process called curing. Temporary dental restoration using resin is
technologically useful applications for dental treatment. |
| | Above technological characteristics of the subject device is identical to
the predicate device. |
| | Materials
The subject device is composed of the each raw material whose safety were
evaluated by suppliers and the results were indicated on MSDS. Moreover,
the Resin for Temporary Crown & Bridge was evaluated for biocompatibility
based on ISO 10993. |
| | Clinical Tests
The Resin for Temporary Crown & Bridge and the cited predicate device were
not conducted clinical tests to determine substantial equivalence. |
| | Non-clinical Tests
Non-clinical testing was performed in order to validate the product against
the company's specified design requirement.
The Resin for Temporary Crown & Bridge in all variants were tested with
respect 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 the
insolubility is in compliance with the requirements of the standard. There is
no evidence that effects hazardous to the patient will arise by leachable
ingredients/contaminants.
The composition of the Resin for Temporary Crown & Bridge exhibits
sufficient strengths and performances in all intraoral conditions and will
sufficiently resist compressive & tensile loads, hardness, water sorption and
solubility. |
| | Sterilization
The Resin for Temporary Crown & Bridge and the cited predicate device are
provided non-sterile. |
| | Performance Specification
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. |
| Conclusion | It is adequate for the intended use and it shows that there are no
significant differences between the Resin for Temporary Crown &
Bridge and the predicate device currently being marketed that would
adversely affect the use of the product. Any differences in
technological characteristics do not raise new issues of safety or
efficacy.
Therefore, conclusions drawn from testing demonstrate that the
Resin for Temporary Crown & Bridge is substantially equivalent in performance to predicate device. |
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