(127 days)
No
The summary describes a 3D-printable resin material and the required CAD/CAM system, but there is no mention of AI or ML being used in the material itself or the associated manufacturing process described.
No.
The device is a light-curing 3D-printed material used for fabricating permanent and temporary dental restorations like inlays, onlays, veneers, crowns, and bridges, as well as artificial teeth. It is a material used in restorative dentistry, not a therapeutic device designed to treat or cure a disease or medical condition.
No
This device is a material used for fabricating permanent and temporary dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a "resin-based material" and requires a "3D printer" and "post-curing unit," indicating it is a physical material and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that saremco print BRIDGETEC is a material for fabricating dental restorations (inlays, onlays, veneers, crowns, bridges, artificial teeth). This is a material used in the body or to replace parts of the body, not a device used to test samples from the body to diagnose a condition.
- Device Description: The description reinforces that it's a resin-based material for producing dental prosthetics using 3D printing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. saremco print BRIDGETEC does not fit this definition. It is a dental restorative material.
N/A
Intended Use / Indications for Use
saremco print BRIDGETEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print BRIDGETEC material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. saremco print BRIDGETEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBG, PZY
Device Description
saremco print BRIDGETEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.
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
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)
Non-Clinical Performance Testing:
saremco print BRIDGETEC was tested and met the applicable requirements of the following ISO standard:
- ISO 4049:2019 – Dentistry – Polymer-based restorative materials
- ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials
- ISO 22112:2017 – Dentistry – Artificial teeth for dental prostheses
Bench test results allowed us to conclude that saremco print BRIDGETEC meets its intended use.
Biocompatibility:
saremco print BRIDGETEC meets the biocompatibility requirements of the following standards:
- . ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- . ISO 7405:2018 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Clinical Performance Data:
The performance of methacrylate-based polymer resins in the clinical environment has been well established. No human clinical testing was performed to support the substantial equivalence of saremco print BRIDGETEC.
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.
CROWNTEC (Saremco Dental AG) – K213343
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.
TERA HARZ (Graphy Inc.) – K202846
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2023
Saremco Dental AG % Nevine Erian Principal Regulatory Consultant BQC Consulting, LLC 24341 Barbados Dr. Dana Point, California 92629
Re: K232050
Trade/Device Name: saremco print BRIDGETEC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBG, PZY Dated: August 16, 2023 Received: August 17, 2023
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.
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"
1
(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 OS 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).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
K232050
Device Name
saremco print BRIDGETEC
Indications for Use (Describe)
saremco print BRIDGETEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print BRIDGETEC material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. saremco print BRIDGETEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
__ Over-The-Counter Use (21 CFR 801 Subpart C) X Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary
| Submitter | Saremco Dental AG
Gewerbestrasse 4
CH-9445 Rebstein, Switzerland
Establishment Reg. No. N/A | |
|-----------|------------------------------------------------------------------------------------------------------|--|
| Contact | Dr. Christoph Evers
Head of R&D | |
| | Phone +41 71 775 80 90
Fax +41 71 775 80 99
E-Mail christoph.evers@saremco.ch | |
| Official Correspondent | 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
August 15, 2023
| Trade/Device Name | saremco print BRIDGETEC |
|---|---|
| Common Name | Crown, Bridge and Denture Teeth Material |
| Classification Name & | |
| Regulation Number | Tooth Shade Resin Material - 21 CFR 872.3690 |
| Primary Product Code | EBF |
| Other Product Codes | EBG & PZY |
Predicate Devices
CROWNTEC (Saremco Dental AG) – K213343 – Primary Predicate
TERA HARZ (Graphy Inc.) – K202846 – Reference Device
5
Device Description
saremco print BRIDGETEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.
Statement of Intended Use
saremco print BRIDGETEC is a methacrylate-based material for 3D printing of dental restorations.
Statement of Indication for Use
saremco print BRIDGETEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print BRIDGETEC material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. saremco print BRIDGETEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Material Composition
saremco print BRIDGETEC is composed of methacrylate-based resins, dental glass-filler, photo initiators and pigments.
Technological Characteristics
saremco print BRIDGETEC is a light-curing resin for 3D printing.
Non-Clinical Performance Testing
saremco print BRIDGETEC was tested and met the applicable requirements of the following ISO standard:
- ISO 4049:2019 – Dentistry – Polymer-based restorative materials
- ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials
- ISO 22112:2017 – Dentistry – Artificial teeth for dental prostheses
Bench test results allowed us to conclude that saremco print BRIDGETEC meets its intended use.
6
Biocompatibility
saremco print BRIDGETEC meets the biocompatibility requirements of the following standards:
- . ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- . ISO 7405:2018 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Clinical Performance Data
The performance of methacrylate-based polymer resins in the clinical environment has been well established. No human clinical testing was performed to support the substantial equivalence of saremco print BRIDGETEC.
Substantial Equivalence
The technical characteristics of saremco print BRIDGETEC is substantially equivalent to the predicate devices.
Material
saremco print BRIDGETEC is a resin-based material as the predicate devices.
Physical Properties
saremco print BRIDGETEC has similar physical properties as the predicate devices.
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Comparison of saremco print BRIDGETEC to Predicate Devices
| Attribute | saremco print BRIDGETEC | saremco print CROWNTEC | TERA HARZ |
|---|---|---|---|
| Indications | |||
| Intended for both anterior and posterior restorations, including occlusal surfaces. | Yes | Yes | Yes |
| Used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. | Yes | Yes | Yes |
| Used for permanent 3-part bridge restorations | Yes | No | Yes |
| Used for the fabrication of artificial teeth | Yes | Yes | No |
| Used for the fabrication of temporary crowns & bridges. | Yes | Yes | Yes |
| Physical Properties | |||
| Product State | Liquid | Liquid | Liquid |
| Material Type | Methacrylate based resin | Methacrylate based resin | Methacrylate based resin |
| Flexural Strength | Avg. ≥ 135 MPa | Avg. ≥ 135 MPa | Avg. 148.73 MPa |
| Performance Testing | ISO 4049 | ||
| ISO 10477 | |||
| ISO 22112 | ISO 4049 | ||
| ISO 10477 | |||
| ISO 22112 | ISO 4049 | ||
| ISO 10477 | |||
| Attribute | saremco print | ||
| BRIDGETEC | saremco print | ||
| CROWNTEC | TERA HARZ | ||
| Material Attributes | |||
| Chemical | |||
| Characterization | Methacrylate-based | ||
| resins, dental glass- | |||
| filler, photo initiators | |||
| and pigments. | Methacrylate-based | ||
| resins, dental glass- | |||
| filler, photo initiators | |||
| and pigments. | Polyurethane Resin, | ||
| Methacrylate, | |||
| Dimethacrylate, | |||
| Phosphine oxide, | |||
| Butylated | |||
| hydroxytoluene and | |||
| Pigments | |||
| Shelf Life | 2 years | 3 years | 1 year |
| Storage Conditions | Do not expose to | ||
| light | Do not expose to | ||
| light | Do not expose to | ||
| light | |||
| Storage Temperature | 4-28°C (39-82°F) | 4-28°C (39-82°F) | 15-25°C (60-77°F) |
| Technical Attributes | |||
| Product Code(s) | EBF, EBG & PZY | EBF, EBG & PZY | EBF & EBG |
| Fabrication Method | Additive 3D printing | Additive 3D printing | Additive 3D printing |
| UV Laser Wavelength | 385 nm | 385 or 405 nm | 385 or 405 nm |
| Layer Thickness when | |||
| Printing | 50 µm | 50 µm | 50 or 100 µm |
| Polymerization Method | UV Curing Light | UV Curing Light | UV Curing Light |
| Sterile | No | No | No |
| Single Use | No | No | No |
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The differences in the physical properties and chemical compositions between saremco print BRIDGETEC and the predicate devices do not impact safety and effectiveness, as the finished clinical product is a custom-fitted biocompatible restoration regardless of the material variation.
Conclusion
Information provided in this application demonstrates that saremco print BRIDGETEC is substantially equivalent to the predicate devices. saremco print BRIDGETEC shares the same indications for use, similar material composition, similar physical properties and technological characteristics as the predicate devices.