PROCERA SOFTWARE, MODEL 33145 by NOBEL BIOCARE AB

Nobel Biocare's Procera Software imports patient specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings, laminates, and bridges through the use of a 3D-CAD tool. The software also serves as a means of ordering and managing orders of Procera products.

Device Description

The Procera Client Management System (PCMS) software is intended to be used by dental practitioners and dental labs. Through the use of the PCMS software, a customer can import scanned data from the Procera scanners and define the shapes of Procera products through the use of a 3D-CAD tool. The user can then place and manage orders of the resulting Procera dental products.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Procera Software," a 3D-CAD tool for designing dental prosthetic devices and managing orders. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent from the provided text.

Specifically, the document focuses on:

Device Description and Indications for Use: What the software does.
Regulatory Information: Classification, predicate devices, and FDA's substantial equivalence determination.
Procedural Details: Submission dates, contact information, and regulatory compliance advice.

There is no mention of any performance study, clinical trial, or validation testing of the software's accuracy in defining shapes or any other functional aspect.

Summary

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K053602

510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Herbert CraneDirector, Regulatory Affairs
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-5074
Facsimile:	(714) 282-9023
Date of Submission:	December 22, 2005
Classification Name:	Endosseous Implant (21 CFR 872.3640)
Trade or Proprietaryor Model Name:	Procera® Software
Legally Marketed Device(s):	Nobel Biocare - Teeth in an Hour (K030685)Nobel Biocare - Guided Surgery (K050393)

Device Description:

Indications for Use:

Nobel Biocare's Procera Software imports patient specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings, laminates, and bridges through the use of a 3D-CAD tool. The software also serves as a means of ordering and managing orders of Procera products.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an emblem that resembles an abstract eagle or bird-like figure with three curved lines forming the body and head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2006

Nobel Biocare AB C/O Mr. Herbert Crane Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K053602

Trade/Device Name: Procera Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 22, 2005 Received: December 23, 2005

Dear Mr. Crane:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Crane

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vøurs.

Susan Tumner

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Procera Software

Indications For Use:

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quane

Division
Division of Microbiology, General Hospital,
Infection Control, Hospital, Division

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§102(k) Number K053602

1.2

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.)