KERR VPS IMPRESSION MATERIAL

K050604 · Sybron Dental Specialties, Inc. · ELW · Apr 15, 2005 · Dental

Device Facts

• Record ID: K050604
• Device Name: KERR VPS IMPRESSION MATERIAL
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: ELW · Dental
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

The intended use of Kerr VPS Impression Material is for impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions.

Device Story

Kerr VPS Impression Material is an A-silicone impression material designed as an alternative to traditional alginate. It is supplied in 1:1 cartridges for use with the Kerr Extruder or in 5:1 362 mL foil packs for use in commercially available mixing machines. The material is used by dental professionals to capture anatomical impressions for various dental applications, including models, dentures, retainers, and provisional restorations. It features a quick set time, dimensional accuracy, and stability, and is compatible with standard dental disinfection products. The output is a physical dental impression used by the clinician to facilitate the fabrication of dental prosthetics or diagnostic models.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

A-silicone impression material. Supplied in 1:1 cartridges or 5:1 362 mL foil packs. Compatible with Kerr Extruder and standard commercial mixing machines. Class II device (21 CFR 872.3660).

Indications for Use

Indicated for dental impressions in the preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, and provisional crown and bridge restorations.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• 3M ESPE, Position Penta Quick
• DMG, Status Blue Mixstar

Submission Summary (Full Text)

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K050604

sds

APR 1 5 2005

#### SYBRON DENTAL SPECIALTIES

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: March 2005

### Device Name:

- Trade Name -- Kert VPS Impression Material
- Common Name Impression Material
- Classification Name Impression Material, per 21 CFR § 872.3660

# Devices for Which Substantial Equivalence is Claimed:

- 3M ESPE, Position Penta Quick
- DMG. Status Blue Mixstar

#### Device Description:

Kerr VPS impression material is an outstanding A-silicone impression material intended as an alternative to traditional alginate materials. Quick set time, excellent detail reproduction, compatibility with disinfection products, dimensional accuracy and stability make the best alternative. Available in 1:1 cartridges suitable for the Kerr Extruder and in Volume™ 5:1 362 mL foil packs for use in commercially available mixing machines.

# Intended Use of the Device:

The intended use of Kerr VPS Impression Material is for impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions.

# Substantial Equivalence:

Kerr VPS Impression Material is substantially equivalent to other legally marketed devices in the United States. Kerr VPS Impression Material functions in a manner similar to and is intended for the same use as Position Penta Quick and Status Blue Mixstar that are currently marketed by 3M ESPE and DMG, respectively.

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050604

Trade/Device Name: Kerr VPS Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 08, 2005 Received: March 09, 2005

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 ass ontaled as 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 controle provise or cactice, 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 may of 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. Colleen Boswell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issualice of a successfies with other requirements of the Act of that FDA has made a determination mar your con researces. You must comply with any Federal statules and regulations administered by onceess stration and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration a all the Act's requirements, including, but not in increasing reguirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing proclassion product radia labeling (21 CFR Part 801), good manufacturing procession, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produ systellis (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 5 0 local This letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA midnig of succeantal vice 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), please If you desire specific advice for your do not of the regulation entitled, the regulation entitled, a contact the Office of Compliance at (2-10) 27-8 Part 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Bir in of Small "Misbranding of reference to premailer homics the Act from the Division of Small general information of your responsibilities and its toll-free number [phone] or Manufacturers, International and Consulter Assistance as to research industry/support/index.html.

Sincerely yours,

Ques

Chiu S. Lin, PhD 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): {{050604

Device Name: Kerr VPS Impression Material

Indications For Use:

Kerr VPS Impression Material is suitable for impressions in preparation of case study Acr / 1 L 1 mproblem models, opposing models, simple removable dentures, removable models, orniousnats provisional crown and bridge, and dental impressions.

V Prescription Use (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)

| | for K SM |
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| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K050604 |

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