ESTHETICA

K100083 · Kerr Corporation · EBF · Mar 19, 2010 · Dental

Device Facts

• Record ID: K100083
• Device Name: ESTHETICA
• Applicant: Kerr Corporation
• Product Code: EBF · Dental
• Decision Date: Mar 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Esthetica is a composite resin-based block intended for the preparation of inlays, onlays, veneers, full crowns, bridges and crowns for implant restorations.

Device Story

Esthetica is a composite resin-based mill block used for chairside and laboratory fabrication of dental restorations. The device is milled into the desired shape of an inlay, onlay, veneer, crown, or bridge, then cemented into the patient's mouth. It serves as an alternative to porcelain or porcelain/zirconia blocks, designed to mimic the wear, aging, appearance, and function of natural teeth. The device is intended for use by dental professionals in clinical or laboratory settings. It provides a durable, esthetic restorative solution for patients requiring tooth replacement or repair.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing comparing Esthetica to the predicate device (3M ESPE Adult Crown). Evaluated performance characteristics include flexural strength, compressive strength, diametral strength, flexural modulus, fracture toughness, and opacity. Biocompatibility testing was also performed to demonstrate safety.

Technological Characteristics

Composite resin-based mill block. Designed for chairside and laboratory milling. Material properties include flexural strength, compressive strength, diametral strength, flexural modulus, fracture toughness, and opacity. No specific ASTM standards or software algorithms are described.

Indications for Use

Indicated for the preparation of inlays, onlays, veneers, full crowns, bridges, and crowns for implant restorations in patients requiring dental restorative procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• 3M ESPE Adult Crown (Paradigm MZ100 Blocks for CEREC)

Submission Summary (Full Text)

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#### Section III - 510(k) Summary of Safety and Effectiveness

MAR 1 9 2010

#### Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: March 2010

#### Device Name:

- . Trade Name - Esthetica
- . Common Name - Composite Resin-Based Block
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

### Devices for Which Substantial Equivalence is Claimed:

- 3M Company, 3M ESPE Adult Crown .
#### Device Description:

Esthetica is a durable, composite resin-based mill block for chairside and laboratory milling applications. Esthetica is milled as a restoration that is subsequently cemented in place. Esthetica is a highly esthetic, single material, next generation composite block that can be used as an alternative to Porcelain and Porcelain/Zirconia blocks. Esthetica offers Biomimetic features that will wear, age, look, feel, and function like a natural tooth.

#### Intended Use of the Device:

Esthetica is a composite resin-based block intended for the preparation of inlays, onlays, veneers, full crowns, bridges and crowns for implant restorations.

#### Substantial Equivalence:

Esthetica is substantially equivalent to other legally marketed devices in the United States. Esthetica functions in a manner similar to and is intended for the same use as 3M ESPE Adult Crown that is currently marketed as Paradigm MZ100 Blocks for CEREC by 3M Company. A biocompatibility study was completed, which demonstrates that the material is safe for its intended use.

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This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of Esthetica compared to the predicate device, 3M ESPE Adult Crown. The characteristics evaluated include Flexural Strength, Compressive Strength, Diametral Strength, Flexural Modulus, Fracture Toughness and Opacity.

Based upon the biocompatibility test and the bench testing, the clinical performance of Esthetica is substantially equivalent to restorations produced using the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

#### Public Health Service

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

## MAR 1 9 2010

Kerr Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K100083

Trade/Device Name: Esthetica Regulation Number: 21 CFR 872.3690 -Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EBG Dated: January 8, 2010 Received: January 12, 2010

Dear Ms. Garman:

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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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.

ff 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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100083

# Indications for Use

510(k) Number (if known):

Device Name: Esthetica

Indications For Use:

Esthetica is a composite resin-based block intended for the preparation of inlays, onlays, veneers, full crowns, bridges and crowns for implant restorations.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBetz DNS for Dr. K.P. Murley
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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