dima Print Teeth & Temp

K233868 · Kulzer, LLC · EBG · May 23, 2024 · Dental

Device Facts

• Record ID: K233868
• Device Name: dima Print Teeth & Temp
• Applicant: Kulzer, LLC
• Product Code: EBG · Dental
• Decision Date: May 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications - Long-term temporary restorations (up to 6 months), - Teeth for removable dentures

Device Story

dima Print Teeth & Temp is a photopolymer liquid used by dental professionals for 3D printing of individualized dental appliances. The process involves 3D printing, cleaning, and curing the resin to create prosthetic works. The final output is a custom medical device inserted into the patient's oral cavity, adapted to residual teeth or a denture. The device is used in a clinical or laboratory setting by dental healthcare professionals to provide patients with provisional or permanent prosthetic solutions.

Clinical Evidence

Bench testing only. Performance evaluated via physical characteristics testing in accordance with ISO 10477 and ISO 22112 standards. All requirements were met.

Technological Characteristics

Photopolymer resin for 3D printing. Complies with ISO 10477 (polymer-based crown and bridge materials) and ISO 22112 (denture teeth). Offered in various colors. No software or electronic components described.

Indications for Use

Indicated for patients requiring long-term temporary dental restorations (up to 6 months) or teeth for removable dentures.

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

• DENTCA Crown and Bridge (K192806)
• DENTCA Denture Teeth (K172398)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 | [phone] |
| Applicant Contact | Mr. David Vincent |
| Applicant Contact Email | [e-mail] |

| 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) |
|----------------------------|---------------------|
|----------------------------|---------------------|

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.

| 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.

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.