(84 days)
Not Found
No
The description focuses on standard CAD/CAM processes, data transfer, and control of the system, with no mention of AI, ML, or related concepts like learning, adaptation, or complex pattern recognition beyond basic 3D data processing for design and manufacturing.
No
The device is described as software for CAD/CAM fabrication of dental restorations and does not directly treat or diagnose a disease or condition. Its function is to control a manufacturing process.
No
The device is used for the CAD/CAM fabrication of dental restorations and controls the measuring process, processing of measurement data, and export of data to a milling machine. It does not provide a diagnosis of a patient's condition.
No
The device description explicitly states the software is used "with 3M ESPE's Lava system," which is described as an "all-ceramic system for the CAD/CAM fabrication of dental restorations." This indicates the software is part of a larger hardware system (scanner, milling machine) and not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for the CAD/CAM fabrication of dental restorations. This involves designing and preparing physical dental prosthetics.
- Device Description: The description reinforces this by explaining how the software controls the measurement, editing, and export of data for milling.
- Lack of Diagnostic Function: There is no mention of the software being used to diagnose a disease, condition, or state of health. It does not analyze biological samples or provide information for diagnostic purposes.
- Focus on Fabrication: The core function is related to the manufacturing process of dental restorations, not the diagnosis of a patient's condition.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This software's function falls outside of that scope.
N/A
Intended Use / Indications for Use
The Lava software is used with 3M ESPE's Lava system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges.
The software controls the measuring process, processing of the measurement data (3D-CAD tool), and export of the data to the milling machine. In addition, various patient and case information elements can be entered. Other functions are available for verification and service of the measuring system.
The Lava software also facilitates the transfer of 3D data from a scanner to a remote milling machine via internet.
Product codes
NHA, EIH
Device Description
The Lava™ software is used with 3M ESPE's Lava™ system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges. The Lava software controls the measuring process, editing of the measurcment data (CAD), and export of the data to the milling machine. A software module of the Lava satellite scanner facilitates the transfer of 3D data (plain scan data or fully modeled data) to the remote milling machine via internet by a secured internet connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
§ 872.3630 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.)
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
NOV 1 7 2008
Submitter
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann, |
| Manager Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | andreas.petermann@mmm.com |
1
Name of Device
Lava software Proprietary Name: Porcclain powder for clinical use Classification Name All-ceramic core material Common Name: All-ceramic overlay material
Predicate Device:
Procera® Software by Nobel Biocare USA LLC, K053602
Description for the Premarket Notification
The Lava™ software is used with 3M ESPE's Lava™ system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges. The Lava software controls the measuring process, editing of the measurcment data (CAD), and export of the data to the milling machine. A software module of the Lava satellite scanner facilitates the transfer of 3D data (plain scan data or fully modeled data) to the remote milling machine via internet by a secured internet connection.
In summary, Lava™ software as described in this 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.
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 stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Sabine Krisher 3M ESPE AG ESPE Platz D-82229 Seefeld Bavaria GERMANY
NOV 17 2006
Re: K062493
Trade/Device Name: Lava Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, EIH Dated: August 22, 2006 Received: August 25, 2006
Dear Dr. Krischer:
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 grenal 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 offecting 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.
3
Page 2 - Dr. Krischer
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 l'ederal 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suon Pusone
Te-Chia Lin, Ph.D.
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
4
Indications for Use
K062493 510(k) Number (if known):
Device Name: Lava software
Indications For Use: The Lava software is used with 3M ESPE's Lava system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges.
The software controls the measuring process, processing of the measurement data (3D-CAD tool), and export of the data to the milling machine. In addition, various patient and case information elements can be entered. Other functions are available for verification and service of the measuring system.
The Lava software also facilitates the transfer of 3D data from a scanner to a remote milling machine via internet.
Swal Burgess
113 35577-6 318) n of Anesthesiology, General Hospital. n Control, Dental Devic
umber K062493
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)