POINT 4 MODIFIED

K013510 · Sybron Dental Specialties, Inc. · EBF · Jan 18, 2002 · Dental

Device Facts

• Record ID: K013510
• Device Name: POINT 4 MODIFIED
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Point 4 Modified is a dental composite restorative material intended to be used in all classes of cavities

Device Story

Point 4 Modified is a micro-hybrid light-cured resin-based dental restorative material. It contains approximately 79% by weight (59% by volume) inorganic filler with a particle size smaller than traditional micro-hybrids. The device is used by dentists in clinical settings to restore tooth structure in all cavity classes. The material is applied to the cavity and cured with a light source to harden. The smaller filler particle size provides a high, long-lasting polish similar to a microfill composite while maintaining the physical properties of a micro-hybrid. This allows clinicians to achieve aesthetic restorations for patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Micro-hybrid light-cured resin-based dental restorative material. Composition includes approximately 79% by weight (59% by volume) inorganic filler. Features reduced particle size compared to predicate devices to enhance polishability. Form factor is a restorative composite material.

Indications for Use

Indicated for use in all classes of dental cavities in patients requiring restorative treatment.

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

• Kerr Corporation, Prodigy 4

Reference Devices

• Kerr's Herculite XRV

Submission Summary (Full Text)

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JAN 1 8 2002

Image /page/0/Picture/1 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 the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a simple, sans-serif font. The logo is black and white.

K013510

## 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 Colleen Boswell - Contact Person

Date Summary Prepared: October 2001

## Device Name:

- Trade Name Point 4 Modified .
- Common Name -- Dental Composite Restorative Material .
- Classification Name -- Tooth Shade Resin Material, per 21 CFR § 872.3690 .

## Devices for Which Substantial Equivalence is Claimed:

- Kerr Corporation, Prodigy 4 .
#### Device Description:

The device is a micro-hybrid light cured resin-based dental restorative which contains approximately 79% by weight (59% by volume) inorganic filler but with a particle size nearly half that of Kerr's Herculite XRV and Prodigy. This breakthrough in filler technology provides a higher, longer-lasting polish similar to a microfill, without any negative effects to the physical properties.

#### Intended Use of the Device:

The intended use of Point 4 Modified is for use in all classes of cavities.

## Substantial Equivalence:

Point 4 Modified is substantially equivalent to other legally marketed devices in the United States. The dental composite restorative material marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.

> 1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# 'JAN 1 8 2002

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K013510

Trade/Device Name: Point 4 Modified Regulation Number: 872.3690 Regulation Name: Dental Composite Restorative Material Regulatory Class: II Product Code: EBF Dated: October 18, 2001 Received: October 22, 2001

Dear Ms. Boswell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your end 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 Intender conmiser or proces 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 approvisions 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 such additional controls. Existing major regulations affecting (1 will), it may be back 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. Boswell

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours

Kildaloruh

Timot A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Material Center

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K013510 |
| Device Name: | Point 4 Modified |

Indications For Use:

Point 4 Modified is a dental composite restorative material intended to be used in all classes of cavities

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| (k) Number | K013510 |

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)
(Optional Format 1-2-96)