CYRTINA SYSTEM

K063842 · Oratio B.V. · EIH · Apr 17, 2007 · Dental

Device Facts

• Record ID: K063842
• Device Name: CYRTINA SYSTEM
• Applicant: Oratio B.V.
• Product Code: EIH · Dental
• Decision Date: Apr 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System fabricates all-ceramic dental restorations (crowns, bridges, inlays, onlays, veneers, implant abutments). Input: dental impression scanned into computing device. Process: CAD/CAM technology mills zirconia blocks (Cyrtina® BioZyram®); sintered at 1400°C; veneered with Sakura® Interaction powder (Liner/Dentin/Transparent/Incisal). Used in dental labs/clinics; operated by dental professionals. Output: custom dental appliance. Benefit: provides esthetic, durable fixed prosthodontic devices.

Clinical Evidence

No clinical data provided. Evidence based on bench testing of physical/mechanical properties, biocompatibility testing, and historical market use (over 20,000 units placed in Europe since 2000).

Technological Characteristics

Core material: zirconia (green, shaded hexblocks). Veneer material: ceramic powder (Liner/Dentin/Transparent/Incisal). Fabrication: CAD/CAM milling and sintering at 1400°C. Biocompatible materials consistent with predicate devices.

Indications for Use

Indicated for patients requiring all-ceramic dental restorations, including inlays, onlays, veneers, crowns, and bridges.

Regulatory Classification

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.

Predicate Devices

• LAVA Frame (K011394)
• Denzir (K984201)
• DCZirkon (K001815)
• Willi Geller Creation Porcelain (K981490)
• OPC 3G All-ceramic system (K994435)
• IPS Empress 2 (K982616)
• Cercon Ceram Porcelain (K011333)
• KATANA Zirconia (K050160)

Submission Summary (Full Text)

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# KO63842

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# 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 Zel<br>Chief Scientific Officer |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Name of Device | |
| Proprietary Name: | Cyrtina® BioZyram®<br>Sakura® Interaction |
| Classification Name: | Dental ceramic<br>Porcelain powder for clinical use |
| Common Name: | All-ceramic core material<br>All 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

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| Description for the Premarket Notification |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use |
| The CYRTINA SYSTEM is intended to fabricate all-ceramic dental devices like definite crowns and<br>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<br>especially developed for processing for milling at Cyrtina® Center. The five shades are combined<br>with the grouped Cyrtina® Ceram shades |
| Sakura® Interaction is an all-ceramic overlay material in powder form developed for veneering<br>Cyrtina® BioZyram® substructure by layering to provide esthetics and characterization for fixed<br>prosthodontic devices that include both anterior and posterior crowns/bridges and for implant<br>abutments. |
| Sakura® Interaction consists of Liner/Dentin/Transparent/Incisal all-ceramic veneering material. The<br>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<br>computing device. By CAD/CAM technology unfashioned zirconia blocks of Cyrtina® BioZyram®<br>are milled in Cyrtina® Center. After the dental appliance has been milled the piece is sintered at a<br>temperature of 1400°C. For esthetic reasons, the ceramic crown, bridge or abutment, resp. is veneered<br>by Sakura® Interaction. |
| Cyrtina® dental restorations have been on the European market since 2000 with over twenty thousand<br>units placed. |
| Technological characteristics |
| All chemical ingredients for the core material and the veneer and heat-press material are already<br>contained in predicate devices. Additionally, biocompatibility tests were carried out for the core and<br>veneer/press material. The results show that Cyrtina® is a safe device. |
| To provide evidence for the effectiveness of the Cyrtin® system, the physical and mechanical<br>properties have been compared to predicate devices. |
| We believe that theprior use of the components of CYRTINA SYSTEM in legally marketed devices,<br>the performance data provided, the biocompatibility tests results, and the historical use of the device in<br>Europe 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

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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.

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## 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 [phone]. 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 [phone] or [phone] 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

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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

OR

Over-the counter use: ם

(Per 21 CFR 801.109)

(optional Format 1-2-96)

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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

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