The edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM Block are hybrid glass blocks used for the fabrication of indirect single-tooth restorations using CAD/CAM technology. The edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK are available in the three different variants T-BLOCK and i-BLOCK and five shades.

T-BLOCKs are highly translucent blocks that mimic the optical properties of natural enamel. C-BLOCKs are high chromatic blocks corresponding to the color shades A0, A1, A2 and A3. i-BLOCKs are highly translucent and highly chromatic blocks, which have a pre-produced Ti-base interface.

The uniqueness of the edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK lies in the manufacturing process, in which a hybrid glass block is produced by the patented process of vitrification and laser sintering. As a result, the edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK combines the properties of the current CAD/CAM systems in a single block. It has properties comparable to those of feldspar glass-ceramics.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating "substantial equivalence" of a new medical device to a predicate device already on the market. This type of submission is not a traditional clinical study or performance evaluation with acceptance criteria and reported device performance in the way a diagnostic AI device or drug might be. Instead, it relies on demonstrating that the new device has similar technological characteristics and performs similarly to known devices, implying it is equally safe and effective.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document. I will fill in the available information and explicitly state when information is not present or not relevant to this type of regulatory submission.

1. A table of acceptance criteria and the reported device performance

For a 510(k) for dental materials like this, "acceptance criteria" are typically defined by recognized consensus standards and a comparison to the predicate device. The "reported device performance" is essentially demonstrating that the new device meets or exceeds the predicate's performance in key physical properties.

Acceptance Criterion (Implicitly defined by comparison to predicate and standards)	Reported Device Performance (New Device: edelweiss CAD/CAM BLOCKs/Ceramir CAD/CAM BLOCKs)	Predicate Device (BRILLIANT Crios) Performance	Result (Compared to Predicate)
Regulation Number: §872.3690	§872.3690	§872.3690	Substantially Equivalent
Class: II	II	II	Substantially Equivalent
Product Code: EBF	EBF	EBF	Substantially Equivalent
Indications for Use: (Crowns, inlays, onlays, veneers, implant-supported crowns)	T-BLOCK and C-BLOCK: Crowns, inlays, onlays, veneers, implant-supported crowns; i-BLOCK: Implant-supported crowns	Crowns, inlays, onlays, veneers, implant-supported crowns	Substantially Equivalent (same intended use and permanent tooth restorations)
Physical State: Cured blocks	Cured blocks	Cured blocks	Substantially Equivalent
Structure: Polymer resin / ceramic hybrid composite	Polymer resin / ceramic hybrid composite	Polymer resin composite	Substantially Equivalent
Resin Matrix Monomers: (Contains Bis-GMA and UDMA)	Bis-GMA, UDMA, EBPADMA	Bis-GMA, Bis-EMA, TEGDMA, UDMA	Substantially Equivalent (both contain Bis-GMA and UDMA)
Filler: Silica, barium glass	Silica, barium glass	Silica, barium glass	Substantially Equivalent
Sizes: 12, 14	12, 14	12, 14	Substantially Equivalent
Flexural Strength: (Compared to predicate, e.g., ~198 MPa)	200 (MPa)	198 (MPa)	Substantially Equivalent
Flexural Modulus: (Compared to predicate, e.g., ~10.3 GPa)	20 (GPa)	10.3 (GPa)	Substantially Equivalent
Compressive Strength: (Compared to predicate, e.g., ~426 MPa)	550 (MPa)	426 (MPa)	Substantially Equivalent
Packaging: Mandrel mounted; five to a box	Mandrel mounted; five to a box	Mandrel mounted; five to a box	Substantially Equivalent
Usage: Single Patient, multiple use	Single Patient, multiple use	Single Patient, multiple use	Substantially Equivalent
Sterility: Non-Sterile	Non-Sterile	Non-Sterile	Substantially Equivalent
Biocompatibility: Conforms with ISO 10993-1	Conforms with ISO 10993-1	Conforms with ISO 10993-1	Substantially Equivalent
Performance: Conforms with ISO 4049, ISO 10477	Conforms with ISO 4049, ISO 10477	Conforms with ISO 4049	Substantially Equivalent

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes non-clinical performance testing of material properties, not a clinical trial with a "test set" of patient data. The "test set" would refer to the samples of the material used for physical and chemical testing. The sample sizes for these material tests are not explicitly stated in this summary, but they would have been conducted according to the relevant ISO standards (e.g., ISO 4049, ISO 10477) for mechanical properties, which specify minimum sample numbers. The data provenance would be from laboratory testing conducted by or on behalf of edelweiss dentistry products gmbh, likely in Austria or Germany (where the applicant and correspondent are located). This would be prospective laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert readers or "ground truth" established by experts in the context of medical image analysis or diagnosis. The "ground truth" for the material properties are the measurements obtained through standardized laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication method is relevant for this type of material testing. The results are from direct physical and chemical measurements.

5. 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

Not applicable. This is not an AI-based device or a diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance relies on measurements derived from recognized consensus standards and internal test protocols for physical and biocompatibility properties (e.g., flexural strength, compressive strength, biocompatibility according to ISO 10993-1). The "ground truth" is therefore objective laboratory measurement data.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

October 18, 2024

Edelweiss Dentistry Products GmbH % Leonie Zeller QA/RA Engineer Medagent GmbH Griesweg 47 Mühlheim an der Donau, 78570 GERMANY

Re: K241131

Trade/Device Name: edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK Regulation Number: 21 CFR 872.3690

Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: October 1, 2024 Received: October 1, 2024

Dear Leonie Zeller:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

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)

K241131

Device Name edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK Indications for Use (Describe) T-BLOCK and C-BLOCK are used for the following indications - Crowns, inlays, onlays and veneers - Implant-supported crowns The i-BLOCK is used for the following indication: - Implant-supported crowns 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) Premarket Notification

Image /page/4/Picture/2 description: The image shows the word "edelweiss" in a stylized font, with each letter represented by an oval shape with a horizontal line through it. The word "dentistry" is written in smaller letters below the word "edelweiss". The logo is simple and modern, and the use of ovals gives it a unique look.

DATE OF APPLICATION:	24.04.2024		K241131
APPLICANT:	edelweiss dentistry products gmbhDammstraße 686922 WolfurtAustriaTel: +43 (0)5574 62 890-10Fax: +43 (0)5574 62 890-5E-Mail: office@edelweiss-dentistry.com
APPLICANT CONTACT PERSON:	Jakob UnterwegerDirector of Technology & QMTel.: +43 (0)5574 62 890-18E-Mail: j.unterweger@edelweissdentistry.com
CORRESPONDENT:	MEDAGENT GmbHGriesweg 4778570 MühlheimGermanyTel: +49 (0)7463 99540E-Mail: info@medagent.de
CORRSPONDENT CONTACT PERSON:	Leonie ZellerQA/RA ConsultantTel +49 (0)7463 99540

E-Mail: leonie.zeller@medagent.de

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Image /page/5/Picture/1 description: The image shows the word "edelweiss" in a stylized font, with each letter represented by a circle with a horizontal line through it, except for the "w", which is represented by a curved line. Below the word "edelweiss" is the word "DENTISTRY" in a smaller, sans-serif font. The overall design is simple and modern.

1 Device Name

Trade Name:	edelweiss CAD/CAM T-BLOCK;edelweiss CAD/CAM C-BLOCK;edelweiss CAD/CAM i-BLOCK;Ceramir CAD/CAM T-BLOCK;Ceramir CAD/CAM C-BLOCK;Ceramir CAD/CAM i-BLOCK;
Common Name:	CAD/CAM Block
Device Classification Name:	Material, Tooth Shade, Resin

Classification / Product Code 2

The edelweiss CAD/CAM BLOCKs and Ceramir CAD/CAM BLOCKs can be classified according to following device name and product code:

Device	RegulationDescription	RegulationMedicalSpecialty	Review Panel	Product Code	RegulationNumber	DeviceClassification
edelweissCAD/CAM BLOCKCeramirCAD/CAM BLOCK	Tooth shaderesin material	Dental	Dental	EBF	872.3690	II

Predicate Device / Reference Device 3

Device	Predicate Device / Reference Device	510(k) Number	510(k) Holder
edelweiss CAD/CAM BLOCK	BRILLIANT Crios (Primary Predicate Device)	K181500	Coltene/Whaledent AG
Ceramir CAD/CAM BLOCK	Nanocomposite (Reference Device)	K080480	DMG USA, Inc.

4 Device Description

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edelveise

DENTISTRY

5 Indications for Use

T-BLOCK and C-BLOCK are used for the following indications

-Crowns, inlays, onlays and veneers
-Implant-supported crowns

The i-BLOCK is used for the following indication:

Implant-supported crowns -

б Technological Characteristics

The technological characteristics of edelweiss CAD/CAM BLOCK and Ceramir CAD/CAM BLOCK are the same as the technological characteristics of the predicate device.

6.1 Device Characteristics Table

Company	edelweiss dentistryproducts gmbh(New Device)	Coltene/Whaledent AG(Predicate Device)	DMG USA, Inc.(Reference Device)	Result
Device Name	edelweiss CAD/CAMBLOCKCeramir CAD/CAM BLOCK	BRILLIANT Crios	Nanocomposite
Regulation Number	§872.3690	§872.3690	§872.3690	Substantially Equivalent
Class	II	II	II	Substantially Equivalent
Product Code	EBF	EBF	EBF	Substantially Equivalent
510(k) number	K241131	K181500	K080480	-
Review Panel	Dental	Dental	Dental	Substantially Equivalent
Indications for Use	T-BLOCK and C-BLOCK areused for the followingindications- Crowns, inlays,onlays andveneers- Implant-supportedcrownsThe i-BLOCK is used forthe following indication:- Implant-supportedcrowns	BRILLIANT Crios isindicated for:- Crowns, inlays,onlays andveneers- Implant-supportedcrowns	Nanocomposite isindicated for:Restorations of allcavity classesFabrication of directinlays, onlays andindirect veneersCore build-up aftertooth preparationwith the root canalpostMachinableComposite forRestorationsIndirectInlays/Onlays	Substantially Equivalent,the new device andpredicate device have thesame intended use andare used for permanenttooth restorations.
Physical State	Cured blocks	Cured blocks	Viscous paste	Substantially Equivalent
Structure	Polymer resin /ceramic hybridcomposite	Polymer resincomposite	Polymer resin /ceramic hybridcomposite	Substantially Equivalent
Resin Matrix Monomers	Bis-GMA, UDMA,EBPADMA	Bis-GMA, Bis-EMA,TEGDMA, UDMA	Bis-GMA, UDMA,EBPADMA	Substantially Equivalent,the new device andpredicate device bothcontain Bis-GMA andUDMA in their resinmatrix.
Filler	Silica, barium glass	Silica, barium glass	Silica, barium glass	Substantially Equivalent
Sizes	12, 14	12, 14	n/a	Substantially Equivalent
Flexural Strength	200 (MPa)	198 (MPa)	100 (MPa)	Substantially Equivalent

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Image /page/7/Picture/1 description: The image shows the logo for Edelweiss Dentistry. The logo is a stylized version of the word "edelweiss", with each letter represented by a circle with a horizontal line through it. The "w" is represented by a curved line. Below the logo is the word "DENTISTRY" in smaller, sans-serif font.

Company	edelweiss dentistryproducts gmbh(New Device)	Coltene/Whaledent AG(Predicate Device)	DMG USA, Inc.(Reference Device)	Result
Flexural Modulus	20 (GPa)	10.3 (GPa)	-	Substantially Equivalent
Compressive Strength	550 (MPa)	426 (MPa)	300 (MPa)	Substantially Equivalent
Packaging	Mandrel mounted; five toa box	Mandrel mounted; five toa box	Syringe (3g)	Substantially Equivalent
Usage	Single Patient, multipleuse	Single Patient, multipleuse	Single Patient, multipleuse	Substantially Equivalent
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Substantially Equivalent
Biocompatibility	Conforms with ISO 10993-1	Conforms with ISO 10993-1	Conforms with ISO 10993-1	Substantially Equivalent
Performance	Conforms withISO 4049ISO 10477	Conforms withISO 4049	Conforms withISO 4049	Substantially Equivalent

7 Non-Clinical Performance Testing

As part of demonstrating substantial equivalence of edelweiss CAD/CAM BLOCKs and Ceramir CAD/CAM BLOCKs to the predicate device, edelweiss dentistry products gmbh submitted final finished devices for extensive testing in accordance with recognized consensus standards and voluntary standards, as well as to the company's own internal test protocols.

Testing evaluated flexural strength, flexural modulus, compressive strength and biocompatibility of the subject device, as well as other related physical properties. The subject device passed all required testing.

Substantial Equivalence Summary / Conclusion 8

Based on available 510(k) information provided herein our edelweiss CAD/CAM BLOCKs and Ceramir CAD/CAM BLOCKs have the same intended use, indications for use and are fabricated into permanent tooth restorations using the same CAD/CAM manufacturing methods as the predicate device BRILLIANT Crios. In addition to that our edelweiss CAD/CAM BLOCKs and Ceramir CAD/CAM BLOCKs have the same clinical, biological and technological characteristics as the predicate device BRILLIANT Crios. Any minor differences in the materials used to make the subject device when compared to the predicate device have been successfully evaluated by edelweiss dentistry products gmbh through extensive performance and biocompatibility testing on their device. such that the information submitted to the FDA demonstrates that the subject device is as safe and effective as the predicate device and does not raise any new questions of safety and effectiveness. edelweiss CAD/CAM BLOCKs and Ceramir CAD/CAM BLOCKs, as designed and manufactured by edelweiss dentistry products gmbh, have been determined to be substantially equivalent to BRILLIANT Crios blocks.

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.