(78 days)
Not Found
No
The description focuses on standard CAD/CAM design tools and data transfer, with no mention of AI or ML capabilities.
No.
The device is a software for CAD design of dental restorations and abutments, which is a design tool that aids in the manufacturing process rather than directly providing a therapeutic effect to a patient.
No
Explanation: The device is described as software for CAD design of dental restorations and order management, not for diagnosing medical conditions. It assists in the design and manufacturing process, not in identifying diseases or conditions.
Yes
The device is described as a "software device" and a "software package." While it interacts with a scanner and facilitates data transfer for manufacturing, the 510(k) submission specifically focuses on the software's design functionality and does not include the scanner or manufacturing equipment as part of this specific submission.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the CAD design of dental restorations and order management. This is a design and manufacturing process, not a diagnostic test performed on biological samples.
- Device Description: The description clearly states it's a software package for designing dental abutments based on scanned data from a dental plaster model. It's part of a CAD/CAM system for creating physical dental restorations.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing information for the diagnosis, treatment, or prevention of disease.
The device falls under the category of "Optical Impression Systems for CAD/CAM" which are classified as Class II devices for dental applications, not IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA, NOF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)
0
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, | |
| Head of Corporate Regulatory Affairs | ||
| Institut Straumann AG | ||
| Phone: | +41 61 965 14 12 | |
| Fax: | +41 61 965 11 02 | |
| E-mail: | Toni.Joergensen@Straumann.com | |
| Submitter: | Dr. Andreas Petermann, | |
| Head of Regulatory Affairs | ||
| Straumann CADCAM GmbH | ||
| Phone: | +49-89-30 90 75 191 | |
| Fax: | +49-89-30 90 75 119 | |
| E-mail: | Andreas.Petermann@Straumann.com | |
| Date: | September 25, 2009 | |
| Name of Device | ||
| Proprietary Name: | etkonTM es1 | |
| etkonTM visual | ||
| Straumann CARES | ||
| Classification Name: | Optical Impression Systems for CAD/CAM | |
| Endosseous Dental Implant Abutment | ||
| Common Name: | 3D Dental Lab Scanner | |
| Dental Restoration Design Software | ||
| 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
1
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.
2
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 (800) 638-2041 or (301) 796-7100 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
4
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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