(215 days)
Not Found
No
The description focuses on traditional CAD/CAM technology, scanning, milling, dyeing, and sintering processes. There is no mention of AI or ML in the intended use, device description, or the specific sections indicating their presence.
No.
The document describes the Lava™ system, which is used for CAD/CAM fabrication of all-ceramic dental restorations and abutments, and is classified as an endosseous dental implant abutment. It is a prosthetic component for rehabilitation, not a device directly involved in diagnosing, treating, or preventing a disease or condition in a therapeutic manner.
No
The device is described as "intended for CAD/CAM fabrication of all-ceramic dental restorations" and "used for the manufacturing of inlays, onlays, veneers, crowns and bridges." It is a manufacturing system for prosthetic components, not a diagnostic device.
No
The device description clearly outlines the use of physical components like zirconia mill blanks, dyeing liquids, a CNC milling unit (Lava™ Form), and a sintering furnace (Lava™ Therm) for the fabrication of dental abutments. While CAD/CAM technology is mentioned for design, the core of the device involves physical manufacturing processes and materials.
Based on the provided text, the Lava™ system and its components (Lava™ Frame, Lava™ Frame Shade, and the resulting abutments) are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "CAD/CAM fabrication of all-ceramic dental restorations" and "manufacturing of abutments." This is a manufacturing process for medical devices (dental prosthetics), not a diagnostic test performed on biological samples outside the body.
- Device Description: The description details the materials and manufacturing process for creating dental abutments and other restorations. It describes a system for designing, milling, dyeing, and sintering these components.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) to diagnose a disease or condition. Its function is to create a physical prosthetic.
- Classification: The Lava™ abutment is classified as an "endosseous dental implant abutment (21 C.F.R. § 872.3630)," which is a classification for a dental prosthetic component, not an IVD.
In summary, the Lava™ system is a manufacturing system for dental prosthetics, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Lava™ system is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. Lava™ Frame and Lava™ Frame Shade are intended for the manufacturing of abutments.
Product codes
NHA
Device Description
Lava™ abutment made from Lava™ Frame zirconia mill blanks and dyed with Lava™ Frame Shade is classified as cndosseous dental implant abutment (21 C.F.R. § 872.3630) because it is a prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Lava™ Frame and Lava™ Frame Shade are parts of the Lava™ system (K011394). Lava™ Frame Zirconia mill blanks are used for the fabrication of frameworks for allceramic restorations. The frameworks for onlays, inlays, veneers, crowns and bridges are designed and manufactured by CAD/CAM technology, whereas the CAM fabricated Lava™ Abutments made from Lava™ Frame Zirconia mill blanks will be designed by means of a traditional wax up technique. The wax up will be scanned (Lava™ Scan, K062493) and milled without any further design step in the CNC milling unit Lava™ Form. After milling, the abutments are dyed with one of the 7 Lavat 10 Frame Shade dyeing liquids as required to achieve the desired tooth color, then sintered. The dyed abutments are sintered using the specialized program of the Lava™ Therm sintering furnace.
The wax up designed abutment will be cemented to a titanium interface which will be subsequently screwed into the respective implant (e.g. Camlog, Altatec Biotechnologies).
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
ALTATEC Camlog Implant System and Abutments by Altatec Biotechnologies
Reference Device(s)
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
4 510(k) Summary of Safety and Effectiveness
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 |
| Date: | July 23, 2007 |
| Name of Device | |
| Proprietary Name: LavaTM Frame, LavaTM Frame Shade |
| Classification Name: | Porcelain powder for clinical use |
|---|---|
| Endosseous dental implant abutment | |
| Common Name: | All-ceramic core material |
| All-ceramic stain solution | |
| Abutment |
Predicate Device
ALTATEC Camlog Implant System and Abutments by Altatec Biotechnologies .........................................................................................................................................
1
KC72053
Description for the Premarket Notification
Lava™ abutment made from Lava™ Frame zirconia mill blanks and dyed with Lava™ Frame Shade is classified as cndosseous dental implant abutment (21 C.F.R. § 872.3630) because it is a prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Lava™ Frame and Lava™ Frame Shade are parts of the Lava™ system (K011394). Lava™ Frame Zirconia mill blanks are used for the fabrication of frameworks for allceramic restorations. The frameworks for onlays, inlays, veneers, crowns and bridges are designed and manufactured by CAD/CAM technology, whereas the CAM fabricated Lava™ Abutments made from Lava™ Frame Zirconia mill blanks will be designed by means of a traditional wax up technique. The wax up will be scanned (Lava™ Scan, K062493) and milled without any further design step in the CNC milling unit Lava™ Form. After milling, the abutments are dyed with one of the 7 Lavat 10 Frame Shade dyeing liquids as required to achieve the desired tooth color, then sintered. The dyed abutments are sintered using the specialized program of the Lava™ Therm sintering furnace.
The wax up designed abutment will be cemented to a titanium interface which will be subsequently screwed into the respective implant (e.g. Camlog, Altatec Biotechnologies).
The comparison for composition, performance data and indications for use shows that Lava™ abutment made from Lava™ Frame and dyed with Lava™ Frame Shade is substantially equivalent to the predicate device.
In summary, it can be concluded that safety and effectiveness requirements for Laya™ Frame and Lava™ Frame Shade for the fabrication of abutments are completely met.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz Seefeld, Bavaria GERMANY D-82229
MAR 2 9 2011
Re: K072055
Trade/Device Name: Lava™ Frame, Lava™ Frame Shade Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 18, 2008 Received: February 21, 2008
Dear Dr. Soegiarto:
This letter corrects our substantially equivalent letter of February 26, 2008.
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 (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 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.
3
Page 2- Dr. Soegiarto
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Turner
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
| 510(k) Number (if known): | K072055 |
|---|---|
| Device Name: | Lava™ Frame, Lava™ Frame Shade |
| Indications For Use: | The Lava™ system is intended for CAD/CAM fabrication of all-ceramic dental restorations. |
| The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. |
Lava™ Frame and Lava™ Frame Shade are intended for the manufacturing of abutments.
The titanium connection for the abutment must meet the following dimensions:
- Overall cementation surface > 30 mm²
- Height of the head of the titanium interface from the shoulder > 2.8 mm
The following systems fulfill the above described specifications:
Co. Alitec Dental GmbH: Camlog Titanium base for Ceramic abutment. Abutment ø ≥ 4.3 mm
-
Co. Alltec Dental GmbH: Camlog Titanium-base for Ceramic-abutment - Abutment a ≥ 4.3 mm
-
Co. Dentsply Friadent GmbH: Friadent Cera Base
-
Co. Neoss GmbH: Neo Link Neoss Mono Abutment Titanium; Neo Link Neoss Multi Abutment Titanium; Neo Link Neoss Mono Aesthetic Abutment Titanium; Neo Link Neoss Multi Aesthetic Abutment Titanium; Matrix Abutment Hex - Regular Mono Titan; Matrix Abutment Hex - Regular Multi Titan; Matrix Abutment Hex - Narrow Mono Titan; Matrix Abutment Hex - Narrow Multi Titan; Matrix Abutment C-Lect - Regular Mono Titan; Matrix Abutment, C-Lect - Regular Multi Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment ST - Mono Titan; Matrix Abutment ST - Mono Titan
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 Qevice Evaluation (ODE)
Susan Ware
(Division Sign-Off) Division of Anesthesiology, Ger ral Hospital Infection Control, Dental Devices
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510(k) Number: K072033