(29 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a dental resin, with no mention of AI or ML technology.
No
This device is a material used to fabricate temporary crowns and bridges, not a device that directly treats a disease or condition. Its purpose is to physically restore or replace dental structures.
No
The device is a material used to fabricate temporary crowns and bridges, which is a therapeutic rather than a diagnostic function.
No
The device is a resin-based material, which is a physical substance, not software. The description clearly identifies it as a "polymer-based material" used for fabricating temporary crowns and bridges.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fabricate temporary crowns and bridges." This is a material used in the mouth for a restorative dental procedure.
- Device Description: It's described as a "resin-based material" and a "self-curing composite" used for "direct and indirect fabrication of temporary crowns and bridges." This further confirms its use as a dental material for in-vivo application.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any such diagnostic testing on biological samples.
The information provided clearly indicates that Fixtemp® C&B 4:1 is a dental material used for creating temporary restorations within the patient's mouth, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Practice/Dental Laboratory
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: > 60 MPa
Water Sorption:
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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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510(k) Summary K241226
| Submitter | Dreve Dentamid GmbH
Max-Planck-Strasse 31
59423 Unna, Nordrhein-Westfalen, Germany
Establishment Reg. No. 1000486347 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Ms. Anke Hüttenbrauck
Head of Quality Management & Regulatory Affairs
Phone +49 2303 8807 14
Fax +49 2303 8807 581
E-Mail Anke.Huettenbrauck@dreve.de |
| Official Correspondent | Ms. Nevine Erian
Regulatory Consultant
BQC Consulting LLC
24341 Barbados Dr.
Dana Point, CA 92629
Phone (949) 370-7155
Fax (949) 240-8829
E-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
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.
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 to | ||
| fabricate temporary crowns and | ||
| bridges | 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 of | |
| multifunctional | ||
| (meth)acrylates, glass | ||
| powder, aerosil, | ||
| polyester, catalyst and | ||
| pigments. | Mixture of | |
| multifunctional | ||
| (meth)acrylates, glass | ||
| powder, aerosil, | ||
| polyester, catalyst and | ||
| pigments. | ||
| 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 or | |
| thermoforming blank | Impression or | |
| thermoforming 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 |