Fixtemp® C&B 4:1 is an automatically mixable self-curing composite, used for the direct and indirect fabrication of temporary crowns and bridges. Fixtemp C&B 4:1 is a Type 1 – polymer-based material, per ISO 10477:2020. It is available in the tooth colors A1, A2, A3, A3.5, B1 and Bleach X.

AI/ML Overview

1. A table of acceptance criteria and the reported device performance

Attribute	Acceptance Criteria (from predicate Fixtemp® C&B)	Reported Device Performance (Fixtemp® C&B 4:1)
Processing/Working Time	≥ 45 sec	≥ 45 sec
Curing Time in the mouth	≥ 2 - 3 min	≈ 2 - 3 min
Setting Time	≥ 6 min	≥ 6 min
Flexural Strength	> 60 MPa	> 60 MPa
Water Sorption	≤ 40 µg/mm³	≤ 40 µg/mm³
Duration	Short term < 30 days	Short term < 30 days

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set or the data provenance for the non-clinical performance testing. It only states that "Bench test results allowed us to conclude that Fixtemp® C&B 4:1 meets its intended use."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for the performance criteria was established against recognized consensus standards (ISO 10477:2020) and compared to a predicate device, not through expert consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The performance testing was based on compliance with a recognized standard and comparison to a predicate device, not on human interpretation or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental material (temporary crown and bridge resin) and does not involve AI or human readers. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the non-clinical performance testing was based on:

Recognized Consensus Standard: ISO 10477:2020 – Dentistry – Polymer-based crown and veneering materials.
Predicate Device Performance: Comparison to the established performance characteristics of the legally marketed predicate device, Fixtemp® C&B (K171729).

8. The sample size for the training set

Not applicable. This device is a dental material, not a machine learning algorithm, so there is no training set in the typical sense.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set.

Summary

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May 31, 2024

Dreve Denatmid GmbH % Nevine Erian Regulatory Consultant BQC Consulting, LLC 24341 Barbados Dr. Dana Point, California 92629

Re: K241226

Trade/Device Name: Fixtemp® C&B 4:1 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: May 1, 2024 Received: May 2, 2024

Dear Nevine Erian:

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 (OS) 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 medical devices and radiation-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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241226

Device Name

Fixtemp® C&B 4:1

Indications for Use (Describe)

Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary K241226

Submitter	Dreve Dentamid GmbHMax-Planck-Strasse 3159423 Unna, Nordrhein-Westfalen, GermanyEstablishment Reg. No. 1000486347
Contact	Ms. Anke HüttenbrauckHead of Quality Management & Regulatory AffairsPhone +49 2303 8807 14Fax +49 2303 8807 581E-Mail Anke.Huettenbrauck@dreve.de
Official Correspondent	Ms. Nevine ErianRegulatory ConsultantBQC Consulting LLC24341 Barbados Dr.Dana Point, CA 92629Phone (949) 370-7155Fax (949) 240-8829E-mail nevine@bqcconsulting.com
Date Prepared	May 1, 2024
Trade/Device Name	Fixtemp® C&B 4:1
Common Name	Temporary crown & bridge resin
Classification Name	Crown and Bridge, Temporary, Resin
Regulation Number	21 CFR 872.3770
Product Code	FBG

Predicate Device

Fixtemp® C&B (Dreve Dentamid GmbH.) – K171729 – Primary Predicate

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Device Description

Statement of Intended Use

Fixtemp® C&B 4:1 is intended for the production of temporary crowns and bridges.

Statement of Indication for Use

Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.

Material Composition

Fixtemp® C&B 4:1 is a methacrylate-based resin.

Technological Characteristics

Fixtemp® C&B 4:1 is a self-curing resin.

Non-Clinical Performance Testing

Fixtemp® C&B 4:1 was tested and met the applicable requirements of the following FDA Recognized Consensus standard:

. ISO 10477:2020 – Dentistry – Polymer-based crown and veneering materials
Bench test results allowed us to conclude that Fixtemp® C&B 4:1 meets its intended use.

Biocompatibility

Fixtemp® C&B 4:1 meets the biocompatibility requirements of the following standards:

ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
. ISO 7405:2008 Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry

Clinical Performance Data

Not applicable. No human clinical testing was performed to support the substantial equivalence of Fixtemp® C&B 4:1.

Substantial Equivalence

The technical characteristics of Fixtemp® C&B 4:1 is substantially equivalent to the predicate device.

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Material

Fixtemp® C&B 4:1 is a resin-based material as the predicate device.

Physical Properties

Fixtemp® C&B 4:1 has similar physical properties as the predicate device.

Technical Comparison of Fixtemp® C&B 4:1 to Predicate Device

Attribute	Fixtemp® C&B 4:1	Fixtemp® C&B
Indications
Resin based material used tofabricate temporary crowns andbridges	Yes	Yes
Physical Property
Type 1 material per ISO 10477	Yes	Yes
Initiator & Activator	Yes	Yes
In Double Cartridge	Yes	Yes
Uses a Mixing Cannula	Yes	Yes
Paste-like Liquid	Yes	Yes
Self-curing Resin	Yes	Yes
Shades	A1, A2, A3, A3.5, B1,Bleach X	A1, A2, A3, A3.5, B1,Bleach X
Material Attributes
Chemical Characterization	Mixture ofmultifunctional(meth)acrylates, glasspowder, aerosil,polyester, catalyst andpigments.	Mixture ofmultifunctional(meth)acrylates, glasspowder, aerosil,polyester, catalyst andpigments.
Mixing Ratio	4:1 (Base:Catalyst)	10:1 (Base:Catalyst)
Material Type	Paste-like Liquid	Paste-like Liquid
Shelf Life	2 years	2 years
Attribute	Fixtemp® C&B 4:1	Fixtemp® C&B
Technical Attributes
Method of manipulation	Impression orthermoforming blank	Impression orthermoforming blank
Polymerization (Curing Method)	Self-curing resin	Self-curing resin
Processing/Working Time	≥ 45 sec	≥ 45 sec
Curing Time in the mouth	≈ 2 - 3 min	≥ 2 - 3 min
Setting Time	≥ 6 min	≥ 6 min
Flexural Strength	> 60 MPa	> 60 MPa
Water Sorption	≤40 µg/mm³	≤40 µg/mm³
Duration	Short term < 30 days	Short term < 30 days
Sterile	No	No
Environment of Use	Dental Practice/DentalLaboratory	Dental Practice/DentalLaboratory

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The differences in physical properties between Fixtemp® C&B 4:1 and the predicate device do not impact safety and effectiveness, as the finished clinical product meets the same performance requirements regardless of the material variation.

Conclusion

Information provided in this application demonstrates that Fixtemp® C&B 4:1 is substantially equivalent to the predicate device. Fixtemp® C&B 4:1 has the same indications for use, similar material composition, similar physical properties and technological characteristics as the predicate device.

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.