(98 days)
Not Found
No
The summary describes a CAD/CAM system for dental veneers, focusing on materials, design software, and milling processes. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
The device is classified as "Porcelain powder for clinical use" and is used to create veneers for dental crowns, which are restorative rather than therapeutic.
No
Explanation: The device is described as "Porcelain powder for clinical use" used for "production of glass ceramic veneers for 3M ESPE Lava™ Frame Zirconia frameworks," which is a material used for dental restorations, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (ceramic blocks, fusion porcelain, corrective porcelains, liquids) and hardware (Lava milling machine, Lava sintering furnace) used in the production of the dental restoration. While software (Lava Design Software) is mentioned, it is part of a larger system involving physical materials and machinery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia". This describes a process for creating dental restorations, which are medical devices used in vivo (within the body).
- Device Description: The device is described as "Porcelain powder for clinical use" and is used for "production of glass ceramic veneers". This further reinforces its use in creating dental prosthetics.
- Classification: The device is classified as "Porcelain powder for clinical use (21 C.F.R. § 872.6660)". This classification falls under the category of dental devices, not in vitro diagnostic devices.
- Lack of IVD Characteristics: The description does not mention any use for testing samples in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. There is no mention of analyzing biological samples like blood, urine, or tissue.
In summary, the device is a material used in the manufacturing of dental restorations, which are medical devices for use within the patient's mouth. This is distinct from an in vitro diagnostic device, which is used to perform tests on samples outside the body.
N/A
Intended Use / Indications for Use
CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia, manufactured with Lava Design Software and the accordingly released Lava milling machine.
Product codes
EIH
Device Description
Elegant is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Elegant is used for production of glass ceramic veneers for 3M ESPE Lava™ Frame Zirconia frameworks.
Elegant consists of 4 glass ceramic blocks (E1 - E4), from which the veneer is milled. Each ceramic block is available in the two sizes S and M. The veneer is then fused to the Zirconia framework via color-coordinated fusion porcelain (D1 - D10). For smaller adjustments to the restoration, corrective porcelains (CR1 - CR4) can be used. For the tooth colors A4, B4, C3, C4, and D4, the basic shades ("Shade" A - D) must be used. The individual stains S1 (White), S2 (Lemon Yellow), S3 (Orange), S4 (Violet), S5 (Blue), S6 (Dark Brown), and glaze are used for individualization. For the mixing of the fusion porcelain powder and the corrective porcelain, modelling liquid is available; also, for stains and glaze, stain/glaze liquid is available.
For the production of an Elegant restoration, the Lava™ Frame Zirconia framework and the corresponding Elegant veneer are virtually designed on the screen with the Lava™ Design Software. The milling for both parts takes place in the accordingly released Lava™ milling machine with special milling cutters. Subsequently the Lava™ Frame Zirconia framework is shaped and then sintered in the Lava™ sintering furnace. All of the above-mentioned Lava products are manufactured by or for 3M ESPE.
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)
K011394, K98098, K053438, K974231, K994251
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
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091826
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
:
Submitter
SEP 2 5 2009
·
:
| 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. Desi W. Soegiarto, |
| Regulatory Affairs Specialist | |
| Phone: | 011-49-8152-700 1169 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | June 05, 2009 |
Name of Device
| Proprietary Name: | Elegant |
|---|---|
| Classification Name: | Porcelain powder for clinical use |
| Common Name: | Glass ceramics, stains, shades, glaze, liquids |
Predicate Device
| Lava Ceram by 3M ESPE | K011394 - |
|---|---|
| IPS Empress Universal Shade/Stains | |
| by Ivoclar Vivadent | Presumably K98098 |
| Glass Ceramics “Jolly” by 3M ESPE | K053438 |
| Position Penta by 3M ESPE | K974231 |
| Ketac Molar Quick by 3M ESPE | K994251 |
.
1
Description for the Premarket Notification
Elegant is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Elegant is used for production of glass ceramic veneers for 3M ESPE Lava™ Frame Zirconia frameworks.
Elegant consists of 4 glass ceramic blocks (E1 - E4), from which the veneer is milled. Each ceramic block is available in the two sizes S and M. The veneer is then fused to the Zirconia framework via color-coordinated fusion porcelain (D1 - D10). For smaller adjustments to the restoration, corrective porcelains (CR1 - CR4) can be used. For the tooth colors A4, B4, C3, C4, and D4, the basic shades ("Shade" A - D) must be used. The individual stains S1 (White), S2 (Lemon Yellow), S3 (Orange), S4 (Violet), S5 (Blue), S6 (Dark Brown), and glaze are used for individualization. For the mixing of the fusion porcelain powder and the corrective porcelain, modelling liquid is available; also, for stains and glaze, stain/glaze liquid is available.
For the production of an Elegant restoration, the Lava™ Frame Zirconia framework and the corresponding Elegant veneer are virtually designed on the screen with the Lava™ Design Software. The milling for both parts takes place in the accordingly released Lava™ milling machine with special milling cutters. Subsequently the Lava™ Frame Zirconia framework is shaped and then sintered in the Lava™ sintering furnace. All of the above-mentioned Lava products are manufactured by or for 3M ESPE.
The comparison for chemistry, performance data and indications for use shows that Elegant is substantially equivalent to the predicate devices.
In summary, it can be concluded that safety and effectiveness requirements for Elegant are completely met.
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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - 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
SEP 2 5 2009
Re: K091826
Trade/Device Name: Elegant Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 15, 2009 Received: September 18, 2009
Dear Dr. Soegiarto:
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 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 - 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 i 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 (OS) 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 vours.
Wh for
Susan Runner, D.D.S., M.A. Acting Division 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
510(k) Number (if known):
Device Name:
Indications For Use:
Elegant
CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia, manufactured with Lava Design Software and the accordingly released Lava milling machine.
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)
Kari Hurley for MR
(Division Sign-Off) (Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number. K091826