K Number

Device Name

FREEPRINT temp

Manufacturer

DETAX GmbH & Co.KG

Date Cleared

2020-10-27

(266 days)

Product Code

EBG

Regulation Number

872.3770

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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K180657

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material composition and 3D printing process, with no mention of AI or ML for design, analysis, or any other function.

Therapeutic

Yes
The device is intended for the fabrication of temporary dental restorations for use in the oral environment, which is a therapeutic purpose.

Diagnostic

This device is used for the fabrication of temporary dental restorations, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "family of light-cured-component materials" and a "liquid photo-curable material," indicating it is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is the "fabrication of temporary dental restorations." This is a direct therapeutic or restorative application within the oral environment.
Device Description: The device is a material used for 3D printing dental prosthetics. It is a physical material that is placed in the body (temporarily).
Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a disease or condition, or to examine specimens derived from the human body for diagnostic purposes.

IVD devices are used to perform tests on samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a material used to create a physical structure for temporary dental restoration.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

EBG

Device Description

Physical Description: FREEPRINT temp: dimethacrylate based resin 1-component system. Processed (3D printed) using 385nm light source.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral environment

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)

Bench testing was carried out on the following characteristics:
Printers validation: 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. Key result: 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. Key result: 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

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.

K180657

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

Regulation Number and Section

§ 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.

Summary

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

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

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)	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 4
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.,
Ltd.
IV. DEVICE DESCRIPTION
Description:	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.
Physical Description:	FREEPRINT temp: dimethacrylate based resin
1-component system.
Processed (3D printed) using 385nm light source.
V. INTENDED USE /
INDICATION FOR USE
STATEMENT	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.

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

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
Crown & Bridge	FREEPRINT temp
CFR Regulation
Number	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.	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.
Product Code	EBG	EBG
Classification	Class II,
Performance standards	Class II,
Performance standards
Classification
Panel	Dental	Dental
Intended 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.	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.
Technological Characteristics		Same /
different
technological
characteristics	Impact on
safety and
effectiveness
Acrylic Resin	Light-cure resin	Light-cure resin	same	no
Chemical
Characterization	Methacrylate-based resins
with photo-initiator, filler
and pigments	Liquid, light-curing
(meth)acrylate-based one-
component material	Same type of
materials	No, based on
performance
testing & Bio-
compatibility
testing
Polymerization
(Curing) method	Visible light, 405 nm	Visible light, 385 nm	Same
technology,
different wave
length	No, based on
performance
testing & Bio-
compatibility
testing
Fabrication of
Denture Base	Automated printing of resin
in multiple layers, each
light-cured before adding
next layer, with post curing	Automated printing of resin
in multiple layers, each
light-cured before adding
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
polymerization	Bonding after
polymerization	same	no
Residual methyl
methacrylate
monomer	Not applicable, the material
does not contain methyl
methacrylate
Total methyl methacrylate
monomers