The CEREC® inLab and CEREC® Scan Dental Restoration Milling Machines are intended to be used in the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, crowns (full and partial), crown caps and bridge frameworks.

Device Description

The CEREC® inLab and CEREC® Scan are identical stationary dental milling units consisting of the same hardware, software, and operating instructions. The table-top rectangular housing encases the motors, mechanical gears, position sensors, and the milling chamber. The milling chamber contains the laser scanner, two grinding burrs and the spindle for the ceramic block. The milling process is driven by electrical DC motors and stepper motors operating under microprocessor control. The laser scanner, mounted within the milling chamber, is used to scan impressions or models of the tooth or teeth. The scanned data is then transferred to a PC computer either via an RS232 interface cable connected to the serial interface port at the rear of the milling machine or via an optional wireless module. The PC contains the software that is used by the dentist or the dental technician to design the restoration from the scanned data. The restoration is then milled from a ceramic block in the milling chamber under microprocessor control using the design parameters.

AI/ML Overview

This 510(k) summary for the CEREC® inLab and CEREC® Scan Dental Restoration Milling Machines primarily establishes substantial equivalence to a predicate device and focuses on the process of creating dental restorations, rather than detailed performance metrics typically associated with AI-driven diagnostic or prognostic devices. Therefore, much of the requested information (like acceptance criteria for AI performance, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI accuracy) is not explicitly present in this document.

The document discusses the approval of an additional capability (milling bridge frameworks) for an existing milling machine, asserting that the process for this new capability is the same as for previously approved restorations. The focus is on the mechanical and computer-aided design capabilities of the milling machine, not on an AI algorithm making diagnostic or predictive decisions.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way a diagnostic AI device would. The "performance" is primarily described by its equivalence to the predicate device and the functionality of its physical components.

Acceptance Criterion (Implied)	Reported Device Performance
Substantial Equivalence to predicate device (CEREC® 3) in terms of process and design capabilities for dental restorations.	The CEREC® inLab and CEREC® Scan are "substantially equivalent" to CEREC® Scan (K994172). The process for producing bridge frameworks (the new intended use) is "the same as for the other CEREC® restorations."
Ability to perform computer-aided design and milling of ceramic dental restorations, including the new intended use of bridge frameworks.	The device is intended to be used for the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, crowns (full and partial), crown caps and bridge frameworks. The design and milling of bridge frameworks is the new intended use.
Functionality of hardware, software, and operating instructions.	The devices consist of the same hardware, software, and operating instructions. Description of components like motors, gears, sensors, milling chamber, laser scanner, grinding burrs, spindle, PC interface (RS232, wireless).

2. Sample size used for the test set and the data provenance:

Not Applicable/Not provided. This document does not describe a study involving a "test set" in the context of evaluating an AI algorithm's performance on a dataset of patient data. The evaluation is based on engineering similarity and functional equivalence to a predicate device, focusing on the mechanical and CAD/CAM process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable/Not provided. No "ground truth" establishment by experts for a test set is discussed, as the device is not an AI diagnostic tool.

4. Adjudication method for the test set:

Not Applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. An MRMC study is not mentioned as this device is a milling machine for dental restorations, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable/Not provided in the context of AI performance. While the milling machine operates "under microprocessor control" for the milling process, and "the PC contains the software that is used by the dentist or the dental technician to design the restoration," the document doesn't describe a standalone AI algorithm's performance independent of the human user designing the restoration or the physical milling process. The "standalone" aspect described is the machine's ability to mill based on design parameters.

7. The type of ground truth used:

Not Applicable/Not provided in the context of typical AI device evaluation. The "ground truth" for this device would relate to the accuracy and fit of the physical dental restorations produced, and the ability of the machine to mill according to the digital design. This is implicitly covered by demonstrating substantial equivalence to a legally marketed predicate device and the described functionality.

8. The sample size for the training set:

Not Applicable/Not provided. The document does not describe an AI model trained on a dataset. The software is used for design, and the machine for milling, which are deterministic CAD/CAM processes, not machine learning algorithms in the typical sense that require training sets.

9. How the ground truth for the training set was established:

Not Applicable/Not provided. This device does not involve a training set with established ground truth in the context of machine learning.

Summary

{0}------------------------------------------------

K012517

NOV 01 2001

510(k) Summary for CEREC® inLab and CEREC® Scan Dental Restoration Milling Machines

1. SPONSOR

Sirona Dental Systems GmbH Fabrikstraße 31 D-64625 Bensheim Germany

Contact Person: Fritz Kolle Telephone: 49 6251 16 3294

Date Prepared: August 3, 2001

2. DEVICE NAME

Proprietary Name:	CEREC® inLab and CEREC® Scan
Common/Usual Name:	Ceramic Dental Restoration Systems
Classification Name:	Impression Material

3. PREDICATE DEVICES

CEREC® 3 Ceramic Dental Restoration System with Scanning Milling Machine (K994172)

4. INTENDED USE

{1}------------------------------------------------

The design and milling of bridge frameworks is the only new intended use and is the subject of this 510(k) Premarket Notification.

ડ. DEVICE DESCRIPTION

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The CEREC® inLab and CEREC® Scan are substantially equivalent to CEREC® Scan that was cleared for marketing as part of the CEREC® 3 Ceramic Dental Restoration System under K994172. The main difference between the current CEREC® Scanning Milling Machines and the previous model is the additional capability of producing bridge framework restorations. However, the process for producing bridge frameworks is the same as for the other CEREC® restorations. The initial impression of the teeth at issue is made using traditional procedures and materials. The impression is fixed onto the spindle in the milling chamber, and the laser scanner is used to scan the impression. The CEREC® 3 software is then used to design the restoration based on the scanned impression. The resulting design parameters are used to mill the final restoration from the ceramic block.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 1 2001

Sirona Dental Systems GmbH C/O Ms. Sheila Hemeon-Heyer Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760-4153

Re: K012517

Trade/Device Name: Cerec Inlab and Cerec Scan Regulation Number: 872.3660 Regulation Name: Ceramic Dental Restoration Systems Regulatory Class: II Product Code: ELW Dated: August 3, 2001 Received: August 6, 2001

Dear Ms. Heyer:

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.

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

{3}------------------------------------------------

Page 2 - Ms. Heyer

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of all - I outhal the Act's requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice und instills (21 es 11 read in the quality systems (QS) regulation (21 CFR Part 820); and if requirences 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 This lower will and w you to cogne 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

KO12517

NOV 0 1 2001

510(k) Number (if known):

Device Name: CEREC® inLab and CEREC® Scan Dental Restoration Milling Machines

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruder Ruarrez

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices E 1 O(k) Number J

Prescription Use 1 (Per 21 CFR 801.109) OR

Over-The-Counter Use .

(Optional Format 1-2-96)

Sirona Dental Systems GmbH 510(k) CEREC® inLab and CEREC® Scan

August 3, 2001

Page vi

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).