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.

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.

AI/ML Overview

The provided document does not contain information related to an AI/ML device or a multi-reader, multi-case (MRMC) study. The device, "saremco print CROWNTEC," is a light-curing 3D-printed material for dental restorations (e.g., crowns, inlays, veneers, artificial teeth).

The "study" described in the document is a non-clinical performance testing and biocompatibility evaluation of this dental material, specifically to demonstrate its substantial equivalence to predicate devices for FDA 510(k) clearance.

Therefore, I cannot provide answers to the requested information about acceptance criteria, study details, expert involvement, or AI/ML performance metrics, as these are not relevant to the described device and its evaluation process.

Instead, the document details the following:

Acceptance Criteria (inferred from testing): The device (material) was tested and met the applicable requirements of the following ISO standards:
- 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
- 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
Reported Device Performance:
- Flexural Strength: Average ≥ 135 MPa (compared to predicate devices ranging from > 50 MPa to 148.73 MPa).
Study Type: Non-clinical bench testing and biocompatibility assessment.
Ground Truth: The "ground truth" in this context refers to the established requirements and performance metrics defined by the aforementioned ISO standards, against which the material's properties were measured.
Clinical Performance Data: The document explicitly states, "No human clinical testing was performed to support the substantial equivalence of saremco print CROWNTEC."
Training Set/Test Set (as per ML context): Not applicable, as this is a material science characterization, not an AI/ML model development.
Data Provenance: The tests were conducted by the manufacturer (Saremco Dental AG). Data provenance for the material properties would be from the laboratory tests.
Experts and Adjudication: Not applicable in the context of an AI/ML study, but the ISO standards represent a consensus of expert knowledge in dental material science.

Summary

{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 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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K213343

Device Name

saremco print Crowntec

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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
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

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 872.3690Temporary Crown and Bridge Resin – 21 CFR 872.3770Preformed Plastic Denture Tooth – 21 CFR 872.3590
Product Codes	EBF & EBG
Subsequent Product Code	PZY

Predicate Devices

TERA HARZ (Graphy Inc.) – K202846 – Primary Predicate

{4}------------------------------------------------

VarseoSmile Crown®₪ (BEGO Bremer Goldschlägerei) – K201668 – Reference Predicate

Dentca Denture Teeth (Dentca, Inc.) K172398 – Secondary Predicate

Device Description

Statement of Intended Use

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

Statement of Indication for Use

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

{5}------------------------------------------------

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.

{6}------------------------------------------------

Comparison of saremco print CROWNTEC to Predicate Devices

Attribute	saremco printCROWNTEC	TERA HARZ	VarseoSmileCrownplus	DENTCA DentureTeeth
Indications
Intended for both anteriorand posteriorrestorations, includingocclusal surfaces.	Yes	Yes	Yes	No
Used for fabricatingpermanent restorationssuch as inlays, onlays,veneers and full crownrestorations.	Yes	Yes	Yes	No
Used for the fabrication ofartificial teeth	Yes	No	No	Yes
Used for the fabrication oftemporary crowns &bridges.	Yes	Yes	No	No
Physical Properties
Product State	Liquid	Liquid	Liquid	Liquid
Attribute	saremco printCROWNTEC	TERA HARZ	VarseoSmileCrownplus	DENTCA DentureTeeth
Material Type	Methacrylate basedresin	Methacrylate basedresin	Methacrylate basedresin	Methacrylate basedresin
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 4049ISO 10477ISO 22112	ISO 4049ISO 10477	ISO 4049ISO 10477	ISO 22112
Material Attributes
ChemicalCharacterization	Methacrylate-basedresins, dental glass-filler, photo initiatorsand pigments.	Polyurethane Resin,Methacrylate,Dimethacrylate,Phosphine oxide,Butylatedhydroxytoluene andPigments	Methacrylate-basedresins, dental glass-filler, photo initiatorsand pigments.	Methacrylatemonomer,PropylidynetrimethyltrimethacrylateUrethanemethacrylate,Initiators, pigments
Shelf Life	3 years	1 year	2 years	2 years
Storage Conditions	Do not expose tolight	Do not expose tolight	Do not expose tolight	Do not expose tolight
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 printCROWNTEC	TERA HARZ	VarseoSmileCrownplus	DENTCA DentureTeeth
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 whenPrinting	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

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

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.

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.