(266 days)
FREEPRINT temp 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.
FREEPRINT temp is a family of light-cured-component materials for the Digital Light Processing (DLP)-printing of temporary Crowns & Bridges (C&B) material. It is stored in 500 and 1000ml HDPE bottles. It contains materials with colours of A1, A2, and A3 based on the shade guide. This Product is a liquid photo-curable material that is polymerized by UV laser at 385nm. 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 (385nm) by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength lightsource. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 50µm in thickness. Output resolution ranges from 34µm to 75µm on the x, y axis.
I am sorry, but based on the provided text, there is no information about a study that uses AI or machine learning, or medical image analysis. This document is a 510(k) premarket notification for a dental resin called FREEPRINT temp, used for fabricating temporary dental restorations.
The document discusses the device's indications for use, technological characteristics, and comparison to a predicate device. It also mentions performance testing (against ISO standards) and biocompatibility testing, but these are standard tests for physical materials and do not involve AI or medical image analysis.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance related to AI/ML.
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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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 27, 2020
DETAX GmbH & Co.KG % Jan-Paul Van Loon Consultant Qserve Consultancy BV Utrechtseweg 310 - Bldg. B42 Arnhem, 6812 AR NETHERLANDS
Re: K200273
Trade/Device Name: FREEPRINT temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: September 30, 2020 Received: October 1, 2020
Dear Jan-Paul Van Loon:
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
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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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name FREEPRINT temp
Indications for Use (Describe)
FREEPRINT temp 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.
| 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
| I SUBMITTER | |
|---|---|
| Submitter Name: | DETAX GmbH & Co.KG. |
| Submitter Address: | Carl-Zeiss-Stasse 4D-76275 Ettingen, Germany |
| Phone Number: | +49 (0)7243/510-138 |
| Contact Person: | M. (Markus) Stratmann |
| Date Prepared: | October 26, 2020 |
| II. DEVICE | |
| 510(k) number | K200273 |
| Device Trade Name: | FREEPRINT temp |
| Common Name | Temporary crown and bridge resin |
| Classification | 21 CFR 872.3770 |
| Classification Name | Temporary crown and bridge resin |
| Product Code: | EBG |
| Review Panel: | Dental |
| III. PRIMARY PREDICATE DEVICE | K180657, Resin for Temporary Crown & Bridge, Dentis Co.,Ltd. |
| IV. DEVICE DESCRIPTION | |
| Description: | FREEPRINT temp is a family of light-cured-componentmaterials for the Digital Light Processing (DLP)-printing oftemporary Crowns & Bridges (C&B) material. It is stored in500 and 1000ml HDPE bottles. It contains materials withcolours of A1, A2, and A3 based on the shade guide. ThisProduct is a liquid photo-curable material that is polymerizedby UV laser at 385nm. It can be used to make a tooth modelwith a photo-curable polymer that is cured by ultraviolet light.The liquid UV curing resin is cured at a specific wavelength(385nm) by the photo-initiator contained in the resin. Thisdevice can be manufactured with 3D stereolithographic printerwith 385nm wavelength lightsource. Curing in a 3D printer isrelated to the conditions of the printer equipment and istypically 50µm in thickness. Output resolution ranges from34µm to 75µm on the x, y axis. |
| Physical Description: | FREEPRINT temp: dimethacrylate based resin1-component system.Processed (3D printed) using 385nm light source. |
| V. INTENDED USE /INDICATION FOR USESTATEMENT | FREEPRINT temp is indicated for the fabrication of temporarydental restorations in conjunction with extra-oral curing lightequipment. Duration is less than 30 days in oral environment. |
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VI. SUMMARY OF
PERFORMANCE DATA characteristics: AND DESIGN Printers validation ● CONTROLS: Four printers are validated for processing (3D printing) using FREEPRINT temp. Additional printers post-510(k)-clearance will be added to the labelling by means of the Quality Systems and within the validation plan presented in this 510(k). Referenced Standards and Performance Testing: Performance testing confirmed the FREEPRINT temp demonstrated performance to the acceptance criteria referred to ISO 10477 and ISO 7491. The composition of FREEPRINT temp exhibits sufficient strengths and performances in all intraoral conditions and will sufficiently resist compressive & tensile loads, hardness, water sorption and solubility. Biocompatibility testing: FREEPRINT temp in all variants were tested with respect to biocompatibility according to ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11 and ISO 10993-17, taking ISO 7405 into account. The results showed that the insolubility is in compliance with the requirements of the standard. There is no evidence that hazardous effects will arise by leachable ingredients/contaminants. Clinical Tests: No clinical tests were performed with FREEPRINT temp VII. SUMMARY OF FREEPRINT temp has been compared to the Primary TECHNOLOGICAL Predicate device, Resin for Temporary Crown & Bridge, CHARACTERISTICS OF Dentis Co., Ltd. (K180657). Details are provided in Table 1 DEVICE COMPARED below. TO PREDICATE DEVICES Comparison of the FREEPRINT temp has a similar Indications for Use statement Indications for Use as the predicate device. FREEPRINT temp has the following similarities in and technological characteristics as the predicate device: Technological Characteristics: Same type of materials (chemical composition) that form the basis for the device used. - Same technology, both are light curing resins that are cured in a 3D printer. - Similar mechanical and physical properties. Although the devices use a different wavelength for polymerization (curing method), both devices meet the requirements of the same performance and
Bench testing was carried out on the following
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Table 1: Summary of Technological Characteristics of FREEPRINT temp and the Predicate device
| Feature | Primary Predicate device | FREEPRINT temp | ||
|---|---|---|---|---|
| 510(k) Number | K180657 | K200273 | ||
| Manufacturer | Dentis Co., Ltd.. | DETAX GmbH & Co.KG | ||
| Trade name | Resin for TemporaryCrown & Bridge | FREEPRINT temp | ||
| CFR RegulationNumber | 872.3770, Temporarycrown and bridge resin.(a) Identification. Atemporary crown andbridge resin is a devicecomposed of a material,such aspolymethylmethacrylate,intended to make atemporary prosthesis, suchas a crown or bridge, foruse until a permanentrestoration is fabricated. | 872.3770, Temporarycrown and bridge resin.(a) Identification. Atemporary crown andbridge resin is a devicecomposed of a material,such aspolymethylmethacrylate,intended to make atemporary prosthesis, suchas a crown or bridge, foruse until a permanentrestoration is fabricated. | ||
| Product Code | EBG | EBG | ||
| Classification | Class II,Performance standards | Class II,Performance standards | ||
| ClassificationPanel | Dental | Dental | ||
| Intended Use | Resin for TemporaryCrown & Bridge isindicated for the fabricationof temporary dentalrestorations in conjunctionwith extra-oral curing lightequipment. Duration is lessthan 30 days in oralenvironment. | FREEPRINT temp isindicated for the fabricationof temporary dentalrestorations in conjunctionwith extra-oral curing lightequipment. Duration is lessthan 30 days in oralenvironment. | ||
| Technological Characteristics | Same /differenttechnologicalcharacteristics | Impact onsafety andeffectiveness | ||
| Acrylic Resin | Light-cure resin | Light-cure resin | same | no |
| ChemicalCharacterization | Methacrylate-based resinswith photo-initiator, fillerand pigments | Liquid, light-curing(meth)acrylate-based one-component material | Same type ofmaterials | No, based onperformancetesting & Bio-compatibilitytesting |
| Polymerization(Curing) method | Visible light, 405 nm | Visible light, 385 nm | Sametechnology,different wavelength | No, based onperformancetesting & Bio-compatibilitytesting |
| Fabrication ofDenture Base | Automated printing of resinin multiple layers, eachlight-cured before addingnext layer, with post curing | Automated printing of resinin multiple layers, eachlight-cured before addingnext layer, with post curing | same | no |
| in light chamber | in light chamber | |||
| Post Curing | Visible light-curing unit | Visible light-curing unit | same | no |
| Teeth assemble | Bonding afterpolymerization | Bonding afterpolymerization | same | no |
| Residual methylmethacrylatemonomer | Not applicable, the materialdoes not contain methylmethacrylateTotal methyl methacrylatemonomers < 0.1% massfraction | Not applicable, the materialdoes not contain methylmethacrylateTotal methyl methacrylatemonomers < 0.1% massfraction | NA | NA |
| Performancestandards | ISO 10477 Third edition | ISO 10477 Third edition | Same | no |
| Biocompatibility | ISO 7405:2008/A1:2013ISO 10993-1:2009/C1:2010ISO 10993-3:2014ISO 10993-5:2009ISO 10993-10:2010ISO 10993-11:2017 | ISO 7405:2014ISO 10993-1:2018ISO 10993-3:2014ISO 10993-5:2009ISO 10993-10:2013ISO 10993-11:2017 | similar | CurrentlyRecognizedConsensusStandardsApplied |
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VIII. CONCLUSION OF SUBSTANTIAL EQUIVALENCE
FREEPRINT temp and the predicate have the same intended use and similar technological characteristics.
The results of the performed tests show that FREEPRINT temp meets the requirements mentioned in the applicable standards and confirm that the device performs similarly to the predicate device.
lt is therefore concluded that FREEPRINT temp performs as intended and is substantially equivalent to the predicate device.
§ 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.