Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard CAD software for dental prosthetics, focusing on user-driven design and manufacturing output. There are no mentions of AI, ML, or related concepts, nor any descriptions of training or test sets typically associated with such technologies.

Therapeutic

No

This device is a CAD system used for designing dental prosthetic devices, which are then manufactured. It does not directly treat or diagnose a medical condition.

Diagnostic

No

The device is described as software used for designing dental prosthetic devices from digital impressions, not for diagnosing medical conditions or diseases. It creates an output file for manufacturing restorations.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that the Zfx Dental CAD system is software used to design dental restorative prosthetic devices. While it interacts with external scanning systems and manufacturing processes, the core medical device function described is the software-based design tool.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to design dental prosthetic devices based on patient-specific data acquired through scans or digital files. This is a design and manufacturing process for a medical device (dental prosthetics), not a diagnostic test performed on biological samples.
Device Description: The device is software used to design dental restorative prosthetic devices from digital optical impressions. It processes topographical characteristics, not biological samples or data derived from them for diagnostic purposes.
Lack of Diagnostic Claims: There are no mentions of analyzing biological samples, detecting diseases, or providing diagnostic information about a patient's health status.
Input Data: The input data is digital optical impressions or STL files from a scanner, which represent the physical shape of the dental anatomy, not biological markers or samples.

IVD devices are specifically designed to perform tests on specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

NHA, NOF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

STL file from a scanner

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

Not Found

Summary of Performance Studies

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). 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.
Clinical Testing: No clinical testing was performed.

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.)

Summary

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

1. 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

1. 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. _____________________________________________________________________________________________________________________________________________________________________

1. 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.

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.
1. 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