dima Print Teeth & Temp is a photopolymer liquid for 3D printing of dental appliances. Its processing by dental healthcare professionals includes 3D printing, cleaning and curing. The final product produced by dental healthcare professionals will be an individual medical device for a special patient, inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted to a given denture. Dima Print Teeth & Temp is offered in a range of colors.

AI/ML Overview

The provided text is a 510(k) summary for the medical device "dima Print Teeth & Temp". It outlines the general regulatory information, device description, and indications for use. However, it does not contain the detailed information about acceptance criteria, device performance results, sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies that would be expected for a comprehensive study proving the device meets acceptance criteria.

The document states:
"Testing of the physical characteristics as listed in the predicate comparison table was conducted to evaluate the performance of dima Print Teeth & Temp, according to requirements of ISO 10477 and ISO 22112. All requirements were met."

This statement confirms that testing was done and requirements were met, but it does not provide the specific details of the acceptance criteria or the reported performance values. It also explicitly states "Not Applicable" under "Clinical Tests Summary & Conclusions 21 CFR 807.92(b)", indicating that a clinical study of the type described in questions 5, 6, and 7 was not performed or not required for this 510(k) submission.

Therefore, based solely on the provided text, I cannot provide a detailed answer to all parts of your request. I will indicate where the information is not present.

Acceptance Criteria and Device Performance Study for dima Print Teeth & Temp

Based on the provided FDA 510(k) summary (K233868), the device "dima Print Teeth & Temp" was evaluated against performance requirements derived from ISO 10477 and ISO 22112. The summary confirms that "All requirements were met." However, the specific acceptance criteria and the reported numeric performance values are not detailed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (from ISO 10477/22112)	Reported Device Performance
Physical Characteristics	Not explicitly detailed in document	All requirements met
ISO 10477 conformance	e.g., Flexural Strength, Water Sorption, etc. (specific values from standard)	Met ISO 10477 requirements
ISO 22112 conformance	e.g., Color stability, Surface roughness, etc. (specific values from standard)	Met ISO 22112 requirements

Note: The document states that testing was "according to requirements of ISO 10477 and ISO 22112" and that "All requirements were met." However, the specific quantitative acceptance criteria (e.g., "flexural strength > Y MPa") and the measured device performance (e.g., "flexural strength = Z MPa") are not provided in this 510(k) summary. These details would typically be in the full submission documentation.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the performance testing.
The data provenance (e.g., country of origin, retrospective/prospective) is also not provided in this summary. These physical/material tests are typically conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This type of information is generally relevant for studies involving human interpretation (e.g., imaging devices) where expert consensus is needed for ground truth. For physical material properties testing (as indicated by the reference to ISO 10477 and ISO 22112), ground truth is established by standardized test methodologies and measurements, not by expert consensus on human data. Therefore, this question is not applicable in the context of the reported non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in studies where human readers provide subjective assessments that need to be reconciled for ground truth. This was a non-clinical, physical properties test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states "Not Applicable" under "Clinical Tests Summary & Conclusions 21 CFR 807.92(b)". This indicates that a clinical study, including an MRMC study comparing human readers with and without AI assistance, was not performed or not required for this 510(k) submission for this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The device is a "photopolymer liquid for 3D printing of dental appliances," not an AI algorithm. Therefore, a standalone algorithm performance evaluation is not relevant. The device itself is the material.

7. The Type of Ground Truth Used

For the performance testing reported (physical characteristics according to ISO 10477 and ISO 22112), the ground truth is established by standardized laboratory testing procedures and direct physical measurements as defined by the referenced ISO standards. This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The device is a material, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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May 23, 2024

Kulzer, LLC David Vincent Director, QA/RA 4315 S. Lafayette Blvd South Bend, Indiana 46614

Re: K233868

Trade/Device Name: dima Print Teeth & Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, POW, PZY Dated: December 6, 2023 Received: May 2, 2024

Dear David Vincent:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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

Submission Number (if known)

K233868

Device Name

dima Print Teeth & Temp

Indications for Use (Describe)

Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications

Long-term temporary restorations (up to 6 months),
Teeth for removable dentures

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) #:	K233868	510(k) Summary	Prepared on:	2024-05-02
-----------	---------	----------------	--------------	------------

Contact Details	21 CFR 807.92(a)(1)
-----------------	---------------------

Applicant Name	Kulzer, LLC
Applicant Address	4315 S. Lafayette Blvd South Bend IN 46614 United States
Applicant Contact Telephone	(574) 299-5421
Applicant Contact	Mr. David Vincent
Applicant Contact Email	David.Vincent@kulzer-dental.com

Device Name	21 CFR 807.92(a)(2)
-------------	---------------------

Device Trade Name	dima Print Teeth & Temp
Common Name	Temporary crown and bridge resin
Classification Name	Crown And Bridge, Temporary, Resin
Regulation Number	872.3770
Product Code	EBG

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K192806	DENTCA Crown and Bridge	EBG
K172398	DENTCA Denture Teeth	PZY

Device Description Summary	21 CFR 807.92(a)(4)
----------------------------	---------------------

Intended Use/Indications for Use	21 CFR 807.92(a)(5)
----------------------------------	---------------------

Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works.

Indications

Long-term temporary restorations (up to 6 months),
Teeth for removable dentures

Indications for Use Comparison	21 CFR 807.92(a)(5)
--------------------------------	---------------------

In comparison to the predicate device dima Print Teeth & Temp combines the indications of both of the predicate devices (see predicate comparison table). This does not constitute a new intended use.

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Technological Comparison

21 CFR 807.92(a)(6)

ln comparison to the predicate devices, the device dima Print Teeth & Temp has the same technological characteristics as the predicate devices. Therefore, both dima Print Teeth & Temp and the predicates can be considered substantially equivalent.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Testing of the physical characteristics as listed in the predicate comparison table was conducted to evaluate the performance of dima Print Teeth & Temp, according to requirements of ISO 10477 and ISO 22112. All requirements were met. Please see the attachment below for detailed nonclinical testing performed.

Not Applicable.

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.