The Cyrtina system is intended for CAD/CAM fabrication of allceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Device Description

The CYRTINA SYSTEM is intended to fabricate all-ceramic dental devices like definite crowns and bridges. The Cyrtina System consists of two different materials: Cyrtina® BioZyram® is a core material made of zirconia. It is provided as green, shaded hexblocks especially developed for processing for milling at Cyrtina® Center. The five shades are combined with the grouped Cyrtina® Ceram shades. Sakura® Interaction is an all-ceramic overlay material in powder form developed for veneering Cyrtina® BioZyram® substructure by layering to provide esthetics and characterization for fixed prosthodontic devices that include both anterior and posterior crowns/bridges and for implant abutments. Sakura® Interaction consists of Liner/Dentin/Transparent/Incisal all-ceramic veneering material. The final restoration shade matches 16 Vita Lumen shades and four Bleach shades. Cyrtina® dental restorations are fabricated according to a dental impression which is scanned into a computing device. By CAD/CAM technology unfashioned zirconia blocks of Cyrtina® BioZyram® are milled in Cyrtina® Center. After the dental appliance has been milled the piece is sintered at a temperature of 1400°C. For esthetic reasons, the ceramic crown, bridge or abutment, resp. is veneered by Sakura® Interaction.

AI/ML Overview

This document is a 510(k) summary for the Cyrtina® BioZyram® Sakura® Interaction dental material system. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting a comprehensive study with clinical efficacy endpoints a medical device that uses AI might. As such, many of the requested categories related to AI-driven device studies are not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted or inferred from the provided document:

Acceptance Criteria and Device Performance

For this type of device (dental ceramic), performance is typically assessed by comparing physical and mechanical properties to established predicate devices. The document states: "To provide evidence for the effectiveness of the Cyrtin® system, the physical and mechanical properties have been compared to predicate devices."

Acceptance Criteria Category (Inferred)	Reported Device Performance
Biocompatibility	"Biocompatibility tests were carried out for the core and veneer/press material. The results show that Cyrtina® is a safe device." (The specific acceptance criteria or detailed results are not provided in this summary.)
Physical and Mechanical Properties	"The physical and mechanical properties have been compared to predicate devices." "We believe that the prior use of the components of CYRTINA SYSTEM in legally marketed devices, the performance data provided... support the safety and effectiveness of the CYRTINA SYSTEM." (Specific metrics for comparison, acceptance thresholds, or detailed results are not provided in this summary, but the claim is that they are comparable to predicates to demonstrate effectiveness.)
Shade Matching	"The final restoration shade matches 16 Vita Lumen shades and four Bleach shades." (This is a specific performance claim, though not explicitly an "acceptance criterion" in the sense of a pass/fail threshold described here. It indicates a functional performance characteristic.)

Study Details (as applicable to a 510(k) for dental materials):

Sample size used for the test set and the data provenance: Not explicitly stated for specific tests (e.g., biocompatibility, physical properties). The context of a 510(k) for dental materials suggests that standard material testing was performed, but the sample sizes for those tests are not detailed. The device has been on the European market since 2000 with "over twenty thousand units placed," implying extensive real-world usage data, but this is not presented as a formal "test set" for a specific study in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For material performance, "ground truth" is typically established by established ASTM/ISO standards and laboratory measurements, not expert consensus in the way an AI diagnostic device would require.
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: Not applicable. This is not an AI-driven or diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental material system.
The type of ground truth used:
- Biocompatibility: Likely established through standardized in vitro and/or in vivo tests according to ISO standards, with results compared to established safety profiles.
- Physical and Mechanical Properties: Established through laboratory measurements following recognized material testing standards (e.g., ISO, ASTM) and comparison to predicate devices.
The sample size for the training set: Not applicable. This is a material system, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Conclusions from the Document:

The predicate devices mentioned (LAVA Frame, Denzir, DCZirkon, Willi Geller Creation Porcelain, OPC 3G All-ceramic system, IPS Empress 2, Cercon Ceram Porcelain, KATANA Zirconia) demonstrate similar technological characteristics and intended use. The 510(k) summary argues for substantial equivalence based on:

The fact that all chemical ingredients for the core material and veneer are already contained in predicate devices.
Biocompatibility test results showing the device is safe.
Comparison of physical and mechanical properties to predicate devices, demonstrating effectiveness.
Historical use of the device in Europe since 2000 (over twenty thousand units placed).

The FDA's letter states: "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... to legally marketed predicate devices." This substantial equivalence determination implies that the provided data (including the material comparisons and biocompatibility) met the FDA's requirements for marketing this type of device.

Summary

{0}------------------------------------------------

KO63842

II.

....

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 17 2007

Name:	Oratio B.V.
Street:	Cole Porterhof 168
ZIP/Postal Code, City:	1628 TN HOORN
Federal State:	NH
Country:	The Netherlands
Esthablishment Registration Number:	KvK Hoorn 37104336
Contact:	Prof.dr.ir. Jef M. van der ZelChief Scientific Officer
Phone:	+31 229 247660
Fax:	+31 229 247744
E-mail:	jmvanderzel@wxs.nl
Name of Device
Proprietary Name:	Cyrtina® BioZyram®Sakura® Interaction
Classification Name:	Dental ceramicPorcelain powder for clinical use
Common Name:	All-ceramic core materialAll ceramic overlay material
Predicate Devices
LAVA Frame	K 011394 (3M ESPE)
Denzir	K 984201 (Dentronic)
DCZirkon	K 001815 (Austenal)
Willi Geller Creation Porcelain	K 981490 (Jensen Industries)
OPC 3G All-ceramic system	K 994435 (Jeneric Pentron)
IPS Empress 2	K 982616 (Ivoclar)
Cercon Ceram Porcelain	K 011333 (Dentsply)
KATANA Zirconia	K 050160 (Noritake Company)

510(k) Cyrtina® System a Oratio

Premarket Notification v. 1.2

14 - 43

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

Description for the Premarket Notification
Intended Use
The CYRTINA SYSTEM is intended to fabricate all-ceramic dental devices like definite crowns andbridges. The Cyrtina System consists of two different materials:
Cyrtina® BioZyram® is a core material made of zirconia. It is provided as green, shaded hexblocksespecially developed for processing for milling at Cyrtina® Center. The five shades are combinedwith the grouped Cyrtina® Ceram shades
Sakura® Interaction is an all-ceramic overlay material in powder form developed for veneeringCyrtina® BioZyram® substructure by layering to provide esthetics and characterization for fixedprosthodontic devices that include both anterior and posterior crowns/bridges and for implantabutments.
Sakura® Interaction consists of Liner/Dentin/Transparent/Incisal all-ceramic veneering material. Thefinal restoration shade matches 16 Vita Lumen shades and four Bleach shades.
Cyrtina® dental restorations are fabricated according to a dental impression which is scanned into acomputing device. By CAD/CAM technology unfashioned zirconia blocks of Cyrtina® BioZyram®are milled in Cyrtina® Center. After the dental appliance has been milled the piece is sintered at atemperature of 1400°C. For esthetic reasons, the ceramic crown, bridge or abutment, resp. is veneeredby Sakura® Interaction.
Cyrtina® dental restorations have been on the European market since 2000 with over twenty thousandunits placed.
Technological characteristics
All chemical ingredients for the core material and the veneer and heat-press material are alreadycontained in predicate devices. Additionally, biocompatibility tests were carried out for the core andveneer/press material. The results show that Cyrtina® is a safe device.
To provide evidence for the effectiveness of the Cyrtin® system, the physical and mechanicalproperties have been compared to predicate devices.
We believe that theprior use of the components of CYRTINA SYSTEM in legally marketed devices,the performance data provided, the biocompatibility tests results, and the historical use of the device inEurope support the safety and effectiveness of the CYRTINA SYSTEM.

. . .

Image /page/1/Picture/2 description: The image shows the text "510(k) Cyrtina® System" at the top. Below that is the word "Oratio" in a large, bold font. To the left of "Oratio" is a logo. To the right of "Oratio" is a QR code.

Premarket Notification v. 1.2

CYRTINA® – Collaborative Computerized Denustry

)

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2007

Mr. Jef M. van der Zel Chief Scientific Officer Oratio B.V. Cyrtina Center Zwaag Cole Porterhof 168 1628 TN Hoorn THE NETHERLANDS

Re: K063842

Trade/Device Name: CYRTNA SYSTEM, Cyrtina® BioZyram, Sakura® Interaction Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 14, 2007 Received: April 5, 2007

Dear Mr. Jef M. van der Zel:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

Page 2 - Mr. Jef M. van der Zel

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syvette y. Michie MD.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K063842

INDICATIONS FOR USE STATEMENT

(As Required by 21 C.F.R. §801.109)

510(k) Number:

Device Name:

CYRTINA SYSTEM Cyrtina® BioZyram Sakura® Interaction

K063842

Indications for Use:

The Cyrtina system is intended for CAD/CAM fabrication of allceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use: x

Over-the counter use: ם

(Per 21 CFR 801.109)

(optional Format 1-2-96)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices 510(k) Number .................

SuperRunner

a Ji Anastological ry, General Hospital, Jon Control, Donta, Devices

2(k) Number
FCC

Image /page/4/Picture/18 description: The image shows the text "510(k) Cyrtina" on the top line, with a registered trademark symbol next to "Cyrtina". Below that, there is a logo to the left of the word "Oratio". The logo appears to be a stylized image of lungs.

Premarket Notification v. 1.2

7 - 43

tive Computerized D

"""""

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.