FREEPRINT temp

K200273 · Detax GmbH & Co. KG · EBG · Oct 27, 2020 · Dental

Device Facts

• Record ID: K200273
• Device Name: FREEPRINT temp
• Applicant: Detax GmbH & Co. KG
• Product Code: EBG · Dental
• Decision Date: Oct 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

FREEPRINT temp is a dimethacrylate-based, one-component liquid resin used for 3D printing temporary dental crowns and bridges. The material is processed via Digital Light Processing (DLP) stereolithographic printers using a 385nm UV light source. The device is intended for use by dental professionals in a clinical or laboratory setting. The resin is polymerized layer-by-layer (typically 50µm thickness) and requires post-curing in an extra-oral light chamber. The final output is a temporary dental restoration. The device benefits patients by providing a temporary prosthetic solution while a permanent restoration is being fabricated. Clinical decision-making is supported by the restoration's ability to resist intraoral compressive and tensile loads, water sorption, and solubility, as verified by bench testing.

Clinical Evidence

Bench testing only. Performance testing confirmed compliance with ISO 10477 and ISO 7491, demonstrating sufficient strength, hardness, and resistance to water sorption/solubility. Biocompatibility testing was conducted per ISO 10993-3, -5, -10, -11, -17 and ISO 7405, showing no evidence of hazardous effects from leachable ingredients. No clinical tests were performed.

Technological Characteristics

Dimethacrylate-based, one-component liquid resin. Polymerization via 385nm UV light source. 3D stereolithographic printing process. Output resolution 34-75µm. Complies with ISO 10477 (performance) and ISO 10993/7405 (biocompatibility). HDPE bottle packaging.

Indications for Use

Indicated for patients requiring temporary dental restorations (crowns and bridges) for a duration of less than 30 days.

Regulatory Classification

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.

Predicate Devices

• Resin for Temporary Crown & Bridge (K180657)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K200273

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) | <span> <span style="padding-right: 20px;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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## 510(k) Summary

| I SUBMITTER | |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | DETAX GmbH & Co.KG. |
| Submitter Address: | Carl-Zeiss-Stasse 4<br>D-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.,<br>Ltd. |
| IV. DEVICE DESCRIPTION | |
| Description: | FREEPRINT temp is a family of light-cured-component<br>materials for the Digital Light Processing (DLP)-printing of<br>temporary Crowns & Bridges (C&B) material. It is stored in<br>500 and 1000ml HDPE bottles. It contains materials with<br>colours of A1, A2, and A3 based on the shade guide. This<br>Product is a liquid photo-curable material that is polymerized<br>by UV laser at 385nm. It can be used to make a tooth model<br>with a photo-curable polymer that is cured by ultraviolet light.<br>The liquid UV curing resin is cured at a specific wavelength<br>(385nm) by the photo-initiator contained in the resin. This<br>device can be manufactured with 3D stereolithographic printer<br>with 385nm wavelength lightsource. Curing in a 3D printer is<br>related to the conditions of the printer equipment and is<br>typically 50µm in thickness. Output resolution ranges from<br>34µm to 75µm on the x, y axis. |
| Physical Description: | FREEPRINT temp: dimethacrylate based resin<br>1-component system.<br>Processed (3D printed) using 385nm light source. |
| V. INTENDED USE /<br>INDICATION FOR USE<br>STATEMENT | FREEPRINT temp is indicated for the fabrication of temporary<br>dental restorations in conjunction with extra-oral curing light<br>equipment. 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 Temporary<br>Crown & Bridge | FREEPRINT temp | | |
| CFR Regulation<br>Number | 872.3770, Temporary<br>crown and bridge resin.<br>(a) Identification. A<br>temporary crown and<br>bridge resin is a device<br>composed of a material,<br>such as<br>polymethylmethacrylate,<br>intended to make a<br>temporary prosthesis, such<br>as a crown or bridge, for<br>use until a permanent<br>restoration is fabricated. | 872.3770, Temporary<br>crown and bridge resin.<br>(a) Identification. A<br>temporary crown and<br>bridge resin is a device<br>composed of a material,<br>such as<br>polymethylmethacrylate,<br>intended to make a<br>temporary prosthesis, such<br>as a crown or bridge, for<br>use until a permanent<br>restoration is fabricated. | | |
| Product Code | EBG | EBG | | |
| Classification | Class II,<br>Performance standards | Class II,<br>Performance standards | | |
| Classification<br>Panel | Dental | Dental | | |
| Intended Use | Resin for Temporary<br>Crown & Bridge is<br>indicated for the fabrication<br>of temporary dental<br>restorations in conjunction<br>with extra-oral curing light<br>equipment. Duration is less<br>than 30 days in oral<br>environment. | FREEPRINT temp is<br>indicated for the fabrication<br>of temporary dental<br>restorations in conjunction<br>with extra-oral curing light<br>equipment. Duration is less<br>than 30 days in oral<br>environment. | | |
| Technological Characteristics | | Same /<br>different<br>technological<br>characteristics | Impact on<br>safety and<br>effectiveness | |
| Acrylic Resin | Light-cure resin | Light-cure resin | same | no |
| Chemical<br>Characterization | Methacrylate-based resins<br>with photo-initiator, filler<br>and pigments | Liquid, light-curing<br>(meth)acrylate-based one-<br>component material | Same type of<br>materials | No, based on<br>performance<br>testing & Bio-<br>compatibility<br>testing |
| Polymerization<br>(Curing) method | Visible light, 405 nm | Visible light, 385 nm | Same<br>technology,<br>different wave<br>length | No, based on<br>performance<br>testing & Bio-<br>compatibility<br>testing |
| Fabrication of<br>Denture Base | Automated printing of resin<br>in multiple layers, each<br>light-cured before adding<br>next layer, with post curing | Automated printing of resin<br>in multiple layers, each<br>light-cured before adding<br>next 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 after<br>polymerization | Bonding after<br>polymerization | same | no |
| Residual methyl<br>methacrylate<br>monomer | Not applicable, the material<br>does not contain methyl<br>methacrylate<br>Total methyl methacrylate<br>monomers < 0.1% mass<br>fraction | Not applicable, the material<br>does not contain methyl<br>methacrylate<br>Total methyl methacrylate<br>monomers < 0.1% mass<br>fraction | NA | NA |
| Performance<br>standards | ISO 10477 Third edition | ISO 10477 Third edition | Same | no |
| Biocompatibility | ISO 7405:2008/A1:2013<br>ISO 10993-1:2009/C1:2010<br>ISO 10993-3:2014<br>ISO 10993-5:2009<br>ISO 10993-10:2010<br>ISO 10993-11:2017 | ISO 7405:2014<br>ISO 10993-1:2018<br>ISO 10993-3:2014<br>ISO 10993-5:2009<br>ISO 10993-10:2013<br>ISO 10993-11:2017 | similar | Currently<br>Recognized<br>Consensus<br>Standards<br>Applied |

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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.