IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)

K103556 · Ivoclar Vivadent, Inc. · EIH · Apr 13, 2011 · Dental

Device Facts

• Record ID: K103556
• Device Name: IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EIH · Dental
• Decision Date: Apr 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-On Connect (for CAD-On Technique) is intended to be used for the fabrication of: Crowns Splinted crowns 3-4 unit bridges Crown, splinted crown or 3-4 unit bridge placed on top of an implant abutment ._

Device Story

IPS e.max® CAD Crystall/Connect and Add-On Connect are dental materials used in the CAD-On technique for fabricating crowns, splinted crowns, and 3-4 unit bridges, including implant-supported restorations. These materials function as bonding or additive agents to join or modify ceramic components during the restorative process. Used in dental clinics/laboratories by dental professionals; the materials facilitate the structural assembly of prosthetic restorations. The output is a finished, durable dental restoration that restores patient masticatory function and aesthetics.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ceramic-based dental materials (porcelain powder) for CAD/CAM fabrication. Class II device (21 CFR 872.6660). Product code EIH. Materials are biocompatible dental ceramics designed for high-strength restorative applications. No electronic components, software, or energy sources involved.

Indications for Use

Indicated for the fabrication of crowns, splinted crowns, and 3-4 unit bridges, including those placed on implant abutments. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• IPS e.max CAD (K052630)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Ms. Donna Marie Hartnett Director, Quality Assurance Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

APR 1 3 2011

Re: K103556

Trade/Device Name: IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-on Connect (for CAD-On Technique) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: March 23, 2011 Received: March 28, 2011

Dear Ms. Hartnett:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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- Ms. Hartnett ·

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/ucm 115809.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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nh for .

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

Enclosure

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## Indications for Use

## 510(k) Number (if known): K103556

Device Name: IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-On Connect (for CAD-On Technique)

## Indications For Use:

## Intended Use:

IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-On Connect (for CAD-On Technique) is intended to be used for the fabrication of:

> Crowns Splinted crowns 3-4 unit bridges

Crown, splinted crown or 3-4 unit bridge placed on top of an implant abutment ._

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> ence of CDRH, Office of Device Evaluation (ODE) DIV Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

K10 3556