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.

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.

AI/ML Overview

The provided text describes the regulatory clearance of a dental product, "saremco print BRIDGETEC," based on its substantial equivalence to existing predicate devices. It does not present a study proving the device meets acceptance criteria in the way an AI/ML medical device would be evaluated (e.g., using a test set, ground truth, expert readers, etc.).

Instead, the submission focuses on bench testing and comparison of physical and chemical properties to established standards and predicate devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria in the context of AI/ML evaluation. The information provided is about a material, not a diagnostic or prognostic AI algorithm.

However, I can extract the "acceptance criteria" and "reported device performance" from the document in the context of the material's properties and compliance with standards.

Here's the closest possible interpretation of your request based on the provided text:

Acceptance Criteria and Device Performance (for a Dental Material, not an AI/ML Device)

The "acceptance criteria" for saremco print BRIDGETEC are primarily based on its compliance with international standards for dental materials and its substantial equivalence to existing predicate devices in terms of intended use, material composition, and physical properties.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Property)	Reported Device Performance (saremco print BRIDGETEC)
Compliance to ISO Standards:
ISO 4049:2019 – Dentistry – Polymer-based restorative materials	Met applicable requirements
ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials	Met applicable requirements
ISO 22112:2017 – Dentistry – Artificial teeth for dental prostheses	Met applicable requirements
Biocompatibility in compliance with ISO Standards:
ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process	Met biocompatibility requirements
ISO 7405:2018 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry	Met biocompatibility requirements
Physical Property:
Flexural Strength (Comparison to Predicate)	Avg. ≥ 135 MPa (Similar to predicate saremco print CROWNTEC, and comparable to TERA HARZ's 148.73 MPa)
Material/Technical Attributes (Equivalence to Predicates):
Product State	Liquid
Material Type	Methacrylate based resin
Chemical Characterization	Methacrylate-based resins, dental glass-filler, photo initiators, and pigments.
Shelf Life	2 years (Similar to TERA HARZ, different from CROWNTEC)
Storage Conditions	Do not expose to light
Storage Temperature	4-28°C (39-82°F)
Fabrication Method	Additive 3D printing
UV Laser Wavelength	385 nm
Layer Thickness when Printing	50 µm
Polymerization Method	UV Curing Light
Sterile	No
Single Use	No
Intended Use (Equivalence to Predicates):
Intended for both anterior and posterior restorations, including occlusal surfaces.	Yes
Used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations.	Yes
Used for permanent 3-part bridge restorations	Yes (Note: Predicate CROWNTEC does not have this indication)
Used for the fabrication of artificial teeth	Yes (Note: Predicate TERA HARZ does not have this indication)
Used for the fabrication of temporary crowns & bridges.	Yes

The following points cannot be addressed as they are relevant to AI/ML device studies, not traditional material clearances:

Sample sizes used for the test set and the data provenance: Not applicable. Performance was based on bench tests of the material, not a "test set" of patient data for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing, not expert interpretation of cases.
Adjudication method for the test set: Not applicable.
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: Absolutely not applicable. This is a material, not an AI assisting human readers. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of saremco print BRIDGETEC."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For material properties, the "ground truth" is derived from physical and chemical measurements performed according to established ISO standards. For the "substantial equivalence" claim, the ground truth is the documented performance and indications of the legally marketed predicate devices.
The sample size for the training set: Not applicable. This is a manufactured product, not a software algorithm that requires a "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a regulatory submission for a dental material, not an AI/ML medical device. Therefore, the questions related to AI/ML study design, such as ground truth establishment via experts, reader studies, and training/test sets, are not relevant to this content. The "proof" of meeting "acceptance criteria" for this device lies in its compliance with material standards and demonstrating substantial equivalence through bench testing.

Summary

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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"

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(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

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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)

K232050

Device Name

saremco print BRIDGETEC

Indications for Use (Describe)

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 AGGewerbestrasse 4CH-9445 Rebstein, SwitzerlandEstablishment Reg. No. N/A
Contact	Dr. Christoph EversHead of R&D
	Phone +41 71 775 80 90Fax +41 71 775 80 99E-Mail christoph.evers@saremco.ch

Official Correspondent	Nevine ErianRegulatory ConsultantBQC Consulting, LLC24341 Barbados Dr.Dana Point, CA 92629Phone (949) 370-7155Fax (949) 240-8829E-mail nevine@bqcconsulting.com
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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

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Device Description

Statement of Intended Use

saremco print BRIDGETEC is a methacrylate-based material for 3D printing of dental restorations.

Statement of Indication for Use

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.

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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 4049ISO 10477ISO 22112	ISO 4049ISO 10477ISO 22112	ISO 4049ISO 10477
Attribute	saremco printBRIDGETEC	saremco printCROWNTEC	TERA HARZ
Material Attributes
ChemicalCharacterization	Methacrylate-basedresins, dental glass-filler, photo initiatorsand pigments.	Methacrylate-basedresins, dental glass-filler, photo initiatorsand pigments.	Polyurethane Resin,Methacrylate,Dimethacrylate,Phosphine oxide,Butylatedhydroxytoluene andPigments
Shelf Life	2 years	3 years	1 year
Storage Conditions	Do not expose tolight	Do not expose tolight	Do not expose tolight
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 whenPrinting	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.

Regulation Number and Section

§ 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.