METAMORPHOSIS

K091023 · Kerr Corporation · EBF · May 21, 2009 · Dental

Device Facts

• Record ID: K091023
• Device Name: METAMORPHOSIS
• Applicant: Kerr Corporation
• Product Code: EBF · Dental
• Decision Date: May 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Metamorphosis is intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic / composite veneers, core buildups and incisal abrasions.

Device Story

Metamorphosis is a light-cured, nanohybrid, resin-based dental restorative material. It is designed for direct placement by dental professionals in clinical settings. The material is used for various restorative procedures, including cavity filling, repair of enamel defects, porcelain repair, and core buildups. As a restorative composite, it provides structural support and aesthetic correction for damaged or decayed teeth. It is applied directly to the tooth structure and cured using a dental light source to achieve hardening. The device benefits patients by restoring tooth function and appearance.

Clinical Evidence

bench testing only

Technological Characteristics

Nanohybrid, light-cured, resin-based dental restorative material. Formulated for direct placement in anterior and posterior teeth.

Indications for Use

Indicated for direct placement in all cavity classes in anterior and posterior teeth, base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic/composite veneers, core buildups, and incisal abrasions.

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

• Herculite Ultra, Kerr Corporation
• Premise Flowable, Kerr Corporation

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a serif font.

K091023

MAY 2 1 2009

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

Submitter:

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

Date Summary Prepared: April 2009

#### Device Name:

- · Trade Name -- Metamorphosis
- · Common Name Dental Composite Restorative Material
- · Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690

#### Devices for Which Substantial Equivalence is Claimed:

- · Herculite Ultra, Kerr Corporation
- · Premise Flowable, Kerr Corporation

#### Device Description:

Metamorphosis, a nanohybrid composite, is a light-cured, resin-based, dental restorative designed for direct placement.

#### Intended Use of the Device:

Metamorphosis is intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic / composite veneers, core buildups and incisal abrasions.

#### Substantial Equivalence:

Metamorphosis is substantially equivalent to other legally marketed devices in the United States. Metamorphosis functions in a manner similar to Herculite Ultra and Premise Flowable, all currently marketed by Kerr Corporation.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

### MAY 21 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K091023

Trade/Device Name: Metamorphosis Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, EBC Dated: April 8, 2009 Received: April 10, 2009

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.

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.

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.

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Page 2- Ms. Garman

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runar
Susan Runar, D.D.S., M.A.

Susan Runner, D.D.S., MA Acting 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): K 09 1023

Device Name: Metamorphosis

Indications For Use:

Metamorphosis is intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic / composite veneers, core buildups and incisal abrasions.

Prescription Use V (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)

Kein Mulvey for MSR.
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091023

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