(106 days)
No
The summary describes a 3D-printable material and the required CAD/CAM system, but there is no mention of AI or ML being used in the design, manufacturing, or application of the material or the system. The focus is on the material properties and the manufacturing process.
Yes
saremco print CROWNTEC is a material used for fabricating permanent restorations such as inlays, onlays, veneers, and full crown restorations, and can also be used for artificial teeth and temporary crowns & bridges. These applications are for treating conditions related to dental structure and function, which falls under the definition of a therapeutic device.
No
Explanation: The device is a light-curing 3D-printed material used for fabricating permanent and temporary dental restorations like inlays, onlays, veneers, and full crowns. It is a material used in treatment/restoration, not for diagnosing conditions.
No
The device is a resin-based material for 3D printing, which is a physical substance, not software. While it requires a CAD/CAM system (which includes software), the device itself is the material.
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 CROWNTEC is a material for fabricating dental restorations (inlays, onlays, veneers, crowns, artificial teeth, temporary crowns & bridges). This is a material used in the body or to replace parts of the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces that it's a resin-based material for producing dental restorations 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.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a restorative material used in dentistry.
N/A
Intended Use / Indications for Use
saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Product codes
EBF, EBG, PZY
Device Description
saremco print CROWNTEC 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
Bench test results allowed us to conclude that saremco print CROWNTEC meets its intended use. No human clinical testing was performed to support the substantial equivalence of saremco print CROWNTEC.
Key Metrics
Not Found
Predicate Device(s)
TERA HARZ (Graphy Inc.) – K202846, DENTCA Denture Teeth (Dentca, Inc.) K172398
Reference Device(s)
VarseoSmile Crown®₪ (BEGO Bremer Goldschlägerei) – K201668
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 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.
January 21, 2022
Saremco Dental AG % Nevine Erian Principal Regulatory Consultant BOC Consulting, LLC 24341 Barbados Dr. Dana Point, California 92629
Re: K213343
Trade/Device Name: Saremco Print CROWNTEC Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBF, EBG, PZY Dated: January 5, 2022 Received: January 5, 2022
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
For Michael E. Adjodha, M.ChE. 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
510(k) Number (if known)
Device Name
saremco print Crowntec
Indications for Use (Describe)
saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K213343
| 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 |
| 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 |
| nevine@bqcconsulting.com |
Date Prepared
October 4, 2021
| Trade/Device Name | saremco print CROWNTEC |
|---|---|
| Common Name | Crown, Bridge and Denture Teeth Material |
| Classification Names & | |
| Regulation Numbers | Tooth Shade Resin Material – 21 CFR 872.3690 |
| Temporary Crown and Bridge Resin – 21 CFR 872.3770 | |
| Preformed Plastic Denture Tooth – 21 CFR 872.3590 | |
| Product Codes | EBF & EBG |
| Subsequent Product Code | PZY |
Predicate Devices
TERA HARZ (Graphy Inc.) – K202846 – Primary Predicate
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VarseoSmile Crown®₪ (BEGO Bremer Goldschlägerei) – K201668 – Reference Predicate
Dentca Denture Teeth (Dentca, Inc.) K172398 – Secondary Predicate
Device Description
saremco print CROWNTEC 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 CROWNTEC is a methacrylate-based material for 3D printing of dental restorations.
Statement of Indication for Use
saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Material Composition
saremco print CROWNTEC is composed of methacrylate-based resins, dental glass-filler, photo initiators and pigments.
Technological Characteristics
saremco print CROWNTEC is a light-curing resin for 3D printing.
Non-Clinical Performance Testing
saremco print CROWNTEC 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
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Bench test results allowed us to conclude that saremco print CROWNTEC meets its intended use.
Biocompatibility
saremco print CROWNTEC 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 CROWNTEC.
Substantial Equivalence
The technical characteristics of saremco print CROWNTEC is substantially equivalent to the predicate devices.
Material
saremco print CROWNTEC is a resin-based material as the predicate devices.
Physical Properties
saremco print CROWNTEC has similar physical properties as the predicate devices.
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Comparison of saremco print CROWNTEC to Predicate Devices
| Attribute | saremco print
CROWNTEC | TERA HARZ | VarseoSmile
Crownplus | DENTCA Denture
Teeth |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Indications | | | | |
| Intended for both anterior
and posterior
restorations, including
occlusal surfaces. | Yes | Yes | Yes | No |
| Used for fabricating
permanent restorations
such as inlays, onlays,
veneers and full crown
restorations. | Yes | Yes | Yes | No |
| Used for the fabrication of
artificial teeth | Yes | No | No | Yes |
| Used for the fabrication of
temporary crowns &
bridges. | Yes | Yes | No | No |
| Physical Properties | | | | |
| Product State | Liquid | Liquid | Liquid | Liquid |
| Attribute | saremco print
CROWNTEC | TERA HARZ | VarseoSmile
Crownplus | DENTCA Denture
Teeth |
| Material Type | Methacrylate based
resin | Methacrylate based
resin | Methacrylate based
resin | Methacrylate based
resin |
| Material Color | Various Shades | Various Shades | Various Shades | Various Shades |
| Flexural Strength | Avg. ≥ 135 MPa | Avg. 148.73 MPa | ≥ 116 MPa | > 50 MPa |
| Performance Testing | ISO 4049
ISO 10477
ISO 22112 | ISO 4049
ISO 10477 | ISO 4049
ISO 10477 | ISO 22112 |
| Material Attributes | | | | |
| Chemical
Characterization | Methacrylate-based
resins, dental glass-
filler, photo initiators
and pigments. | Polyurethane Resin,
Methacrylate,
Dimethacrylate,
Phosphine oxide,
Butylated
hydroxytoluene and
Pigments | Methacrylate-based
resins, dental glass-
filler, photo initiators
and pigments. | Methacrylate
monomer,
Propylidynetrimethyl
trimethacrylate
Urethane
methacrylate,
Initiators, pigments |
| Shelf Life | 3 years | 1 year | 2 years | 2 years |
| Storage Conditions | Do not expose to
light | Do not expose to
light | Do not expose to
light | Do not expose to
light |
| Storage Temperature | 4-28°C (39-82°F) | 15-25°C (60-77°F) | 4-28°C (39-82°F) | 15-25°C (60-77°F) |
| Attribute | saremco print
CROWNTEC | TERA HARZ | VarseoSmile
Crownplus | DENTCA Denture
Teeth |
| Technical Attributes | | | | |
| Product Code(s) | EBF, EBG & PZY | EBF & EBG | EBF | PZY |
| Fabrication Method | Additive 3D printing | Additive 3D printing | Additive 3D printing | Additive 3D printing |
| UV Laser Wavelength | 385 or 405 nm | 385 or 405 nm | 405 nm | 385 nm |
| Layer Thickness when
Printing | 50 μm | 50 or 100 μm | 50 μm | 50 or 100 μm |
| Polymerization Method | UV Curing Light | UV Curing Light | UV Curing Light | UV Curing Light |
| Sterile | No | No | No | No |
| Single Use | No | No | No | No |
| Rx or OTC | Rx | Rx | Rx | Rx |
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The differences in the physical properties and chemical compositions between saremco print CROWNTEC 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 CROWNTEC is substantially equivalent to the predicate devices. saremco print CROWNTEC shares the same indications for use, similar material composition, similar physical properties and technological characteristics as the predicate devices.