Who is the manufacturer of ZFX DENTAL CAD SYSTEM?

Zimmer Dental, Inc. filed the 510(k) submission for ZFX DENTAL CAD SYSTEM (K121709).

What is the FDA product code for ZFX DENTAL CAD SYSTEM?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ZFX DENTAL CAD SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ZFX DENTAL CAD SYSTEM?

etkon™ visual (K121709); etkon™ es1 (K121709); Straumann CARES (K121709).

Who can help prepare an FDA 510(k) submission like ZFX DENTAL CAD SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ZFX DENTAL CAD SYSTEM

K121709 · Zimmer Dental, Inc. · NHA · Oct 19, 2012 · Dental

Device Facts

Record ID	K121709
Device Name	ZFX DENTAL CAD SYSTEM
Applicant	Zimmer Dental, Inc.
Product Code	NHA · Dental
Decision Date	Oct 19, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system.

Device Story

Zfx Dental CAD System is a software-based 3D-CAD tool for designing patient-specific dental restorations. Input consists of digital topographical data (STL files) from dental impressions or stone models via a compatible scanner. The software allows users to define shapes for abutments, crowns, bridges, copings, in-lays, on-lays, and veneers. The system generates an output file (STL) transmitted to a Zimmer Dental milling center for manufacturing. Used in dental laboratory settings by trained technicians. The output enables the production of custom prosthetic components, facilitating restorative dental procedures. The system is pre-installed on a Windows-based computer.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed the software's ability to accept digital scan files, design patient-specific restorations, and verify that manufactured components meet design specifications.

Technological Characteristics

Software-based 3D-CAD system; runs on Windows 7 64-bit OS; input/output via STL file format; includes PC, monitor, and network cables. Operates as a design tool for dental prosthetics. No specific material standards or energy sources listed beyond standard computing hardware.

Indications for Use

Indicated for dental professionals to design patient-specific dental prosthetic devices, including abutments, crowns, bridges, copings, in-lays, on-lays, and veneers, using 3D-CAD software based on digital scan data.

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

etkon™ visual (K121709)
etkon™ es1 (K121709)
Straumann CARES (K121709)

Related Devices

K972276 — CEREC 2 CROWN SOFTWARE · Siemens AG · Aug 15, 1997
K200100 — Abutment Design · 3Shape A/S · Oct 7, 2020
K181932 — DTX Studio design · Nobel Biocare AB · Mar 1, 2019
K151455 — 3Shape Abutment Designer Software · 3Shape A/S · Sep 6, 2016
K153036 — NobelDesign Software · Nobel Biocare AB · Jun 2, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ K121709 Image /page/0/Picture/1 description: The image shows a logo for Zimmer Dental. The logo consists of a circle with the letter 'Z' inside, followed by the word 'zimmer' in a stylized font. Below 'zimmer' is the word 'dental' in a smaller, simpler font. ### Zfx Dental CAD System ### Zimmer Dental 510k No.: Page No .: . A5-1 1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax) OCT 19 2012 ### Traditional 510(k) PRE-MARKET NOTIFICATION 510(k) ## 510(k) SUMMARY (21CFR807.92(a)) - 1. Submitter's Information: | Name: | Zimmer Dental Inc. | |----------|---------------------------------------| | Address: | 1900 Aston Ave. Carlsbad, CA 92008 | | Phone: | 760-929-4300 | | Contact: | Cecilia Silva | Date Prepared: October 18, 2012 - 2. Device Name: | Trade Name: | Zfx Dental CAD System | |-----------------------------|-----------------------------------------------------------------------------| | Regulation Number: | 872.3630 / 872.3661 | | Classification Code: | NHA / NOF | | Device Classification Name: | Endosseous Dental Implant Abutment / Optical Impression Systems for CAD/CAM | - 3. Predicate Device(s): Trade Name: etkon™ visual, etkon™ es1, Straumann CARES Regulation Number: 872.3630 / 872.3661 Classification Code: NHA / NOF Device Classification Name: Endosseous Dental Implant Abutment / Optical Impression Systems for CAD/CAM #### র . Device Description: The Zfx Dental CAD system is software that is used to design dental restorative prosthetic devices from digital optical impressions. The software receives topographical characteristics of dental impressions or stone models from a compatible scanning system. The design created in the software is complied into a format enabling manufacturing of a patient specific component at Zimmer Dental. The CAD software is pre-installed on a Windows compatible computer system. {1}------------------------------------------------ Zfx Dental CAD System zummer dental 510(k) No. A5-2 Page No. #### 5. Indications for Use: The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, on-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system. #### Device Comparison: റ. The new device is substantially equivalent to the predicate relative to the software that allows a digital design of patient specific ("customized") abutments, crown, bridge, and components, and the operating software that controls a scanner. The function and intended use of the dental CAD system remains equivalent to the predicate device. {2}------------------------------------------------ Zfx Dental CAD System # zomomo@gr ## dental 510(k) No. A5-3 Page No. _____________________________________________________________________________________________________________________________________________________________________ - 7. Technological Characteristics | Feature/ Components | New Device | Predicate | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Zfx Dental CAD System | etkonTMes1 etkonTM_visual Straumann CARES | | Indication | The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, on-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system. | 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. | | Input | STL file from a scanner | STL file from a scanner | | Design Options | Dental prosthetic devices: Abutments, crowns, bridges, copings, in-lays, on-lays and veneers. | Individual Dental Restorations: Crowns, bridges, inlays, onlays, veneers and abutments. | | Output | STL file to a Zimmer Dental milling center | STL file to a Straumann CAD/CAM milling center | | PC/Monitor | Provided as part of the System | Provided as part of the System | | Network Cables | Provided as part of the System | Provided as part of the System | | GUI/OS | Windows®7 64 bit Operating System | Windows®7 64 bit Operating System | #### Non-Clinical Testing: 8. - a) Verification and Validation Testing . Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005). {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with the letter Z inside, above the word "zimmer" with a line underneath, and the word "dental" below the line. The text is in a simple, sans-serif font. Zfx Dental CAD System 510(k) No. Page No. _____________________________________________________________________________________________________________________________________________________________________ A5-3 Verification and validation testing of the Zfx Dental CAD system has been completed. Validation testing has been conducted to demonstrate that the Zfx Dental CAD system can accept a digital scan file from a compatible dental scanner, and design a patient specific restoration, such as an abutment, crown, or bridge. Verification testing has been conducted to verify that a patient specific restoration can be manufactured by Zimmer to the required design specifications. - ത് Clinical Testing No clinical testing was performed. - 10. Conclusion Based on our analysis, the device is substantially equivalent to the predicate. {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zimmer Dental, Incorporated Ms. Cecilia Silva Regulatory Affairs 1900 Aston Avenue Carlsbad, California 92008 OCT 19 2012 Re: K121709 Trade/Device Name: Zfx Dental CAD System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, NOF Dated: September 17, 2012 Received: September 18, 2012 Dear Ms. Silva: 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. 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. {5}------------------------------------------------ Page 2- Ms. Silva 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/Resourcesfor You/Industry/default.htm. Sincerely vours. Nh for 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 {6}------------------------------------------------ K121709 Image /page/6/Picture/1 description: The image shows a logo for Zimmer Dental. The logo consists of a circle with the letter "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font. Below "zimmer", the word "dental" is written in a smaller, sans-serif font. Indications for Use 21700 510(k) Number (if known): Device Name: Zfx Dental CAD System Indications For Use: The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system. Prescription Use (Part 21 CFR 801 Subpart D) 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) Susan Runez (Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: k121709