ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT

K093113 · Institut Straumann AG · NHA · Dec 18, 2009 · Dental

Device Facts

• Record ID: K093113
• Device Name: ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

etkon_visual is a software device intended to import patient-specific data from a scanner for CAD (computer aided design) design of individual dental restorations like crowns, bridges, inlays, onlays, veneers and abutments. etkon_visual also facilitates the transfer of 3D data from a dental lab to a remote milling center by internet connection and serves as an order management tool.

Device Story

etkon_visual is a dental CAD software package used in dental labs to design customized dental restorations and abutments. It operates in conjunction with the etkon es 1 scanner, which captures 3D data from extraoral dental plaster models with scan bodies. The software processes this scan data to allow technicians to virtually design the shape and size of restorations. Once designed, the digital dataset is transmitted via internet to a remote milling center for manufacturing from zirconium dioxide or titanium blanks. The software also functions as an order management tool. By enabling precise digital design, the device facilitates the production of patient-specific dental prosthetics, improving workflow efficiency for dental professionals.

Clinical Evidence

Bench testing only. Verification and validation efforts confirmed that the software design parameters for individual abutments are met and that the resulting manufactured dental abutments comply with established design specifications.

Technological Characteristics

Software-based CAD system for dental restoration design. Integrates with etkon es 1 optical scanner. Connectivity via internet for data transfer to remote milling centers. Materials for final manufactured abutments include zirconium dioxide and titanium.

Indications for Use

Indicated for the CAD design of individual dental restorations including crowns, bridges, inlays, onlays, veneers, and abutments based on patient-specific data imported from a scanner.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• Straumann Computer-aided Restoration (C.A.R.E.S.) Ceramic Coping (K061277)
• Straumann NN CARES Titanium and Ceramic Abutments
• Straumann WN CARES Titanium Abutment
• P.004 NC CARES Titanium and Ceramic Abutments
• P.004 RC CARES Titanium and Ceramic Abutments
• Straumann Computer aided Restoration Service

Reference Devices

• Procera® Software (Nobel Biocare AB)

Submission Summary (Full Text)

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# 1093113

### 4. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

:

#### Submitter

| | DEC 18 2005 | |
|------------------------------------|------------------------------------------------------------------------------------------|--|
| Company: | Institut Straumann AG | |
| Street: | Peter Merian-Weg 12 | |
| ZIP-Code, City: | CH-4002 Basel | |
| Federal State: | Basel-City | |
| Country: | Switzerland | |
| Establishment Registration Number: | 9613348 | |
| Official Correspondent: | Dr. Toni K. Joergensen,<br>Head of Corporate Regulatory Affairs<br>Institut Straumann AG | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| E-mail: | [e-mail] | |
| Submitter: | Dr. Andreas Petermann,<br>Head of Regulatory Affairs<br>Straumann CADCAM GmbH | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| E-mail: | [e-mail] | |
| Date: | September 25, 2009 | |
| Name of Device | | |
| Proprietary Name: | etkonTM es1<br>etkonTM visual<br>Straumann CARES | |
| Classification Name: | Optical Impression Systems for CAD/CAM<br>Endosseous Dental Implant Abutment | |
| Common Name: | 3D Dental Lab Scanner<br>Dental Restoration Design Software<br>Dental Abutment | |

#### Predicate Devices

.

Straumann Computer-aided Restoration.... K061277 (C.A.R.E.S.) Ceramic Coping Straumann NN CARES............................................................................................................................................................

Titanium and Ceramic Abutments

Straumann WN CARES ........................................................................................................................................................... Titanium Abutment

P.004 NC CARES................................................................................................................................................................ Titanium and Ceramic Abutments

straumann

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P.004 RC CARES................................................................................................................................................................ Titanium and Ceramic Abutments

Straumann Computer aided ..................................................................................................................................................... Restoration Service

Procera® Software ............................................................................................................................................................ Nobel Biocare AB

Description for the Premarket Notification

etkon™ visual is a software package by Institut Straumann AG which allows for digital design of customized abutments.

etkon™ visual is also the operating software that controls Straumann's scanner etkon™ es 1. The scanner etkon™ es 1 together with the application software etkon™ visual fall under the definition of 21CFR872.3661, Optical Impression Systems for CAD/CAM. Such systems are defined as class II devices which are exempt from 510(k) requirements.

This 510(k) premarket notification submission describes etkon™_visual's dental abutment design functionality.

For designing a dental abutment, the etkon™ es 1 scanner collects data from a dental plaster model with a scan body attached intended to provide for the correct positioning of the abutment. The scanning is done extraorally. The scan data is used by the etkon™_visual software design tools to virtually design the shape and size of the dental abutment. Once the design process is finished, the digital dataset is sent to Straumann by internet connection for CAM manufacturing from milling blanks.

The individual abutments that are finally manufactured at Straumann from zirconium dioxide and titanium blanks meet all properties and specifications of Straumann's already 510(k)-cleared individual abutments ("CARES") as listed above in the "Predicate Devices" paragraph.

Image /page/1/Picture/9 description: The image shows two objects that appear to be some type of mechanical or structural components. The object on the left is mostly black, with some white areas, and has a complex shape with a wider top and a narrower bottom. The object on the right is mostly white, with some black areas, and has a simpler shape with a rounded top and a narrower bottom. Both objects are standing upright.

Verification and validation efforts of etkon™ visual provides evidence that design parameters for the individual abutments are met and that dental abutments meeting design specifications are manufactured by Straumann.

In its functionality, etkon™ visual is substantially equivalent to Nobel Biocare's Procera® Software.

In summary, it can be concluded that safety and effectiveness requirements for etkon™ visual for the design of individual dental restorations including abutments are completely met.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Institut Straumann AG C/O Dr. Andreas Petermann Head of Regulatory Affairs Straumann CADCAM GmbH Lochhamer Schlag 6 Graefelfing, Bavaria 82166 GERMANY

JUN 23 2010

Re: K093113

Trade/Device Name: Etkon Visual Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, NOF Dated: September 25, 2009 Received: October 1, 2009

Dear Dr. Petermann:

This letter corrects our substantially equivalent letter of December 18, 2009.

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 (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 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- Dr. Petermann

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Gunner

Image /page/3/Picture/8 description: The image contains a close-up of a handwritten letter 'F'. The letter is written in a cursive style with thick, dark strokes, suggesting it was written with a marker or pen with a broad tip. The background is plain and out of focus, drawing attention to the letter itself.

Anthony D. Watson, B.S., M.S., M.B.A. 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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## Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

etkon_visual

etkon_visual is a software device intended to import patient-specific data from a scanner for CAD (computer aided design) design of individual dental restorations like crowns, bridges, inlays, onlays, veneers and abutments.

etkon_visual also facilitates the transfer of 3D data from a dental lab to a remote milling center by internet connection and serves as an order management tool.

Prescription Use
(Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBatz, DNS for Dr. K.P. Muliy (Acting

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K'093113

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