IMPLANTMASTER

K042212 · I-Dent · LLZ · Oct 21, 2004 · Radiology

Device Facts

• Record ID: K042212
• Device Name: IMPLANTMASTER
• Applicant: I-Dent
• Product Code: LLZ · Radiology
• Decision Date: Oct 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.

Device Story

ImplantMaster is a software interface for dental implant planning. It ingests imaging data from medical scanners (e.g., CT); processes dental professional inputs to simulate implant placement and surgical treatment; and outputs data for use in CAD or Rapid Prototyping Systems. Used by dental professionals in clinical settings to facilitate surgical planning. The system aids clinicians in visualizing and preparing for implant procedures, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

Bench and clinical data provided. Clinical evidence demonstrates that actual implant placement positively matches the pre-operative planning performed by the software. No adverse effects reported.

Technological Characteristics

Software-based interface for medical imaging data transfer and dental surgical planning. Operates as a front-end processor for CAD/Rapid Prototyping systems. Designed in compliance with 21 CFR 820.30.

Indications for Use

Indicated for qualified dental professionals to aid in the planning and simulation of dental implant placement and surgical treatment using imaging data from medical scanners (e.g., CT).

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• SimPlant system (K033847)

Submission Summary (Full Text)

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Ko4 2.212

OCT 2 1 -2004

## 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b))

#### Device Name

Proprietary Device Name : WBR -HR

### Establishment Name and Registration Number of Submitter

Name: 1-Dent Ltd. Corresponding Official: Dan Laor

Yohanan 4, Box 6402 Hod Hasharon 45241. Israel

#### Device Classification

Classification Code: Regulation Number Common Name: Classification Class: 90 LLZ 892 2050 Picture Archiving and Communications System Class II Product

#### Reason for 510(k) Submission

Traditional 510(k) Submission

### Identification of Legally Marketed Equivalent Devices

SimPlant system (K033847)

#### Device Description

The ImplantMaster system is a software interface used for the transfer of imaging information from a medical scanner such as a CT scanner, processing it and planning dental implant placement and surgical treatment. The ImplantMaster processes output result is used as an input data for CAD or Rapid Prototyping System.

#### Intended Use of Device

The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.

#### Safety & Effectiveness

The device has been designed verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that the implant placement positively match the planning. No adverse affects have been detected.

#### Substantial Equivalency

It is I-Dent's opinion that the ImplantMaster is substantially equivalent in terms of safety and effectiveness to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 1 2004

I-DENT % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K042212 Trade/Device Name: ImplantMaster Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: October 4, 2004 Received: October 6, 2004

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becaller be substantially equivalent (for the indications for use stated in above and have determinearketed predicate devices marketed in interstate commerce prior to the clevosale) to regary mantowe of the Medical Device Amendments, or to devices that have been May 20, 1770, the clastinent add serovisions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordantes market approval application (PMA). You may, therefore, market the do not require approvate of a 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 (Premarket 1 ir your device to such additional controls. Existing major regulations affecting your . Apployal), It the Socor of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I rease of advised that i Dr. I be the complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I cacal statues and regulation 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) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow your to ought mading of substantial equivalence of your device to a legally prematice notification: - The sification 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 If you acsife specifice acrise to your be of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, promotion other general information on your responsibilities under the Act from the 601:37). " Ou may octurers, International and Consumer Assistance at its toll-free number (800) DVISIon of Official Manufactures address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. I rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KC4 22/2 510(k) Number (if known):

DEVICE NAME: ImplantMaster

INDICATION FOR USE: The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.

(Please do not write below this line - continue on another page if needed)

( Concurrence of CDRH, Office of Device Evaluation (ODE) )

| | <img alt="signature" src="signature.png"/> |
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| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K042212 |

| Prescription Use ______ | OR Over-the-Counter Use ______ |
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