(87 days)
No
The description focuses on mechanical milling and laser scanning controlled by a microprocessor, with design software running on a separate PC. There is no mention of AI or ML algorithms for design, analysis, or control.
No
This device is a milling machine used for creating dental restorations, which are considered medical devices, but it does not directly treat or diagnose a disease or condition. It is a tool used in the process of creating a restoration, not the therapeutic device itself.
No
The device is described as a milling machine for dental restorations, which creates physical dental devices based on scanned data and design parameters. It does not perform a diagnostic function but rather a manufacturing one.
No
The device description explicitly details hardware components such as motors, mechanical gears, position sensors, a milling chamber, a laser scanner, grinding burrs, and a spindle, indicating it is a physical milling machine with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the computer-aided design and milling of ceramic dental restorations. This is a process performed on materials outside of the human body to create a physical product (dental restoration).
- Device Description: The description details a milling machine that scans impressions or models and then mills a ceramic block. This is a manufacturing process, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes
ELW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Laser scanner
Anatomical Site
Tooth or teeth (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist or dental technician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
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
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.
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:
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.
(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
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