(66 days)
Not Found
No
The summary describes standard image processing and planning software without mentioning AI or ML.
No
The device is a software system used for planning and simulation of dental implant placement, transferring imaging information, and processing data for CAD or Rapid Prototyping Systems. It aids in treatment planning rather than directly providing therapy.
No
The device is used for planning and simulation of dental implant placement and surgical treatment, it does not diagnose a condition or disease.
Yes
The device description explicitly states "The ImplantMaster system is a software interface". While it interacts with hardware (CT scanner, CAD/Rapid Prototyping System), the device itself, as described, is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the ImplantMaster system processes imaging information from a medical scanner (CT scanner) and aids in planning dental implant placement. It does not analyze biological samples like blood, urine, or tissue.
- The primary function is planning and simulation based on imaging data. The software processes imaging data and user input to plan surgical procedures. This is distinct from the diagnostic function of an IVD, which provides information about a patient's health status based on laboratory tests.
The device falls under the category of medical software used for surgical planning and simulation, not in vitro diagnostics.
N/A
Intended Use / Indications 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.
Product codes
90 LLZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified dental professionals
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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.
1
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.
2
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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Page 1 of 1
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) )
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K042212 |
| Prescription Use ______ | OR Over-the-Counter Use ______ |
|---|---|
| ------------------------- | -------------------------------- |