POINT 4 TRANSLUCENT MODIFIED

K013529 · Sybron Dental Specialties, Inc. · EBF · Jan 9, 2002 · Dental

Device Facts

• Record ID: K013529
• Device Name: POINT 4 TRANSLUCENT MODIFIED
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Jan 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Micro-hybrid light-cured resin-based dental restorative material; contains approximately 79% by weight (59% by volume) inorganic filler; smaller particle size than predicate; provides high, long-lasting polish similar to microfill; used by dental professionals in clinical settings for cavity restoration; applied to tooth structure and cured with light; restores tooth form and function.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Micro-hybrid light-cured resin-based dental composite; 79% inorganic filler by weight (59% by volume); smaller particle size than predicate; light-cured; Class II device (21 CFR 872.3690).

Indications for Use

Indicated for use in all classes of dental cavities.

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 Translucent Shades

Reference Devices

• Herculite XRV
• Prodigy

Submission Summary (Full Text)

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4013529

sds

SYBRON DENTAL SPECIALTIES

JAN 0 9 2002

#### 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 Translucent 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 Translucent Shades .
#### 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 Translucent Modified is for use in all classes of cavities.

### Substantial Equivalence:

Point 4 Translucent 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.

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Public Health Service

Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 0 9 2002

Re: K013529

Trade/Device Name: Point 4 Translucent Modified Regulation Number: 872.3690 Regulation Name: Dental Composite Restorative Material Regulatory Class: II Product Code: EBF Dated: October 18, 2001 Received: October 23, 2001

Dear Ms. Boswell:

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 such 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. 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.

Timothy 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

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# Indications for Use Statement

| Ver/3 - 4/24/96 |
|-----------------|
|-----------------|

| Applicant: | Kerr Dental Material Center |
|---------------------------|------------------------------|
| 510(k) Number (if known): | K013529 |
| Device Name: | Point 4 Translucent Modified |
| Indications For Use: | |

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

*Susan Humon*

(Division Sign-Off)

Division of Dental, Infection Control,

General Hospital Devices

| Number | K018309 |
|--------|---------|
|--------|---------|

(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)