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.

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.

AI/ML Overview

This document is a 510(k) Summary for the device "Elegant," a porcelain powder for clinical use in dental restorations. It focuses on establishing substantial equivalence to predicate devices, rather than a traditional clinical study with acceptance criteria for device performance in terms of diagnostic accuracy or similar metrics.

Therefore, many of the requested elements pertaining to acceptance criteria and performance studies are not directly applicable or available in this type of submission, as it's not a clinical performance study evaluating outcomes like sensitivity or specificity. Instead, the "study" is a comparison to predicate devices, and the "acceptance criteria" are the demonstration of substantial equivalence.

Here's an interpretation based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance (vs. Predicate)
Chemistry: Material composition similarities	Elegant consists of glass ceramic blocks (E1-E4), fusion porcelain (D1-D10), corrective porcelains (CR1-CR4), and individual stains (S1-S6) and glazes. These components are assumed to have similar chemical compositions to the predicate devices (Lava Ceram, IPS Empress Universal Shade/Stains, Glass Ceramics “Jolly,” Position Penta, Ketac Molar Quick). The submission explicitly states: "The comparison for chemistry... shows that Elegant is substantially equivalent to the predicate devices."
Performance Data: Physical/mechanical properties	While specific test results (e.g., flexural strength, wear resistance, color stability) are not detailed in this summary, the statement "The comparison for... performance data... shows that Elegant is substantially equivalent to the predicate devices" implies that such data was provided to the FDA and found to meet equivalence. The device's function involves milling and fusing to Zirconia frameworks, necessitating appropriate mechanical properties for dental restorations.
Indications for Use: Clinical application	Elegant is indicated for 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. This indication is deemed substantially equivalent to the indications of the predicate devices. The 510(k) decision letter (K091826) confirms acceptance of these indications for use.
Safety and Effectiveness: Overall assessment	The submission concludes: "In summary, it can be concluded that safety and effectiveness requirements for Elegant are completely met." This is the overarching "acceptance criterion" for a 510(k) submission, meaning the FDA agreed that the device is as safe and effective as the legally marketed predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable in the context of this 510(k) summary. This document does not describe a clinical performance study with a test set of patient data. The "test" for a 510(k) is typically a comparison of device characteristics (chemistry, performance, indications) to existing devices. If any physical or mechanical properties were tested, the sample sizes would refer to experimental batches of materials, not a "test set" of patient data. The manufacturer is based in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission does not involve a diagnostic decision-making process requiring expert ground truth for a test set. The "ground truth" here is regulatory acceptance of equivalence based on the provided technical data and comparisons to predicate devices, reviewed by FDA officials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" or adjudication of diagnostic findings described. The FDA's review process internally involves multiple reviewers, but this is a regulatory review, not a clinical adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a material for dental restorations, not an AI software or diagnostic tool that assists human readers.

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

Not applicable. This device is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is the established characteristics and regulatory acceptance of the predicate devices. The new device's data (chemistry, performance, indications) is compared against these known, legally marketed predicates to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This device is a material, not a machine learning model, so there is no training set.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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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/Stainsby Ivoclar Vivadent	Presumably K98098
Glass Ceramics “Jolly” by 3M ESPE	K053438
Position Penta by 3M ESPE	K974231
Ketac Molar Quick by 3M ESPE	K994251

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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.

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

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Indications for Use

K091826

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

Page 1 of
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510(k) Number. K091826

Regulation Number and Section

§ 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.