EXTRUDE MODIFIED

K012405 · Sybron Dental Specialties, Inc. · ELW · Sep 4, 2001 · Dental

Device Facts

• Record ID: K012405
• Device Name: EXTRUDE MODIFIED
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: ELW · Dental
• Decision Date: Sep 4, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Indications for Use

Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for all crown and bridge, edentulous and implant impression techniques.

Device Story

Extrude Modified is a two-part, base/catalyst polyvinylsiloxane impression material system. Available in three viscosities (Wash, Medium, Extra) and packaged in tubes or cartridges. Used by dental professionals in clinical settings to create accurate dental impressions for crown, bridge, edentulous, and implant procedures. The material is mixed and applied to the patient's oral cavity to capture anatomical structures; it sets to form a physical mold used by dental laboratories to fabricate restorations or prosthetics. Benefits include high-precision replication of dental anatomy for restorative and prosthetic planning.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polyvinylsiloxane impression material; two-part base/catalyst paste system; multiviscosity (Wash, Medium, Extra); supplied in tubes or cartridges. Class II device (21 CFR 872.3660).

Indications for Use

Indicated for dental impression procedures including crown and bridge, edentulous, and implant techniques. No specific age or gender restrictions provided.

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

• Extrude (Kerr Corporation)

Submission Summary (Full Text)

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SEP = 4 2001

Image /page/0/Picture/1 description: The image shows a logo for "Sybron Dental Specialties". The logo features the letters "sds" in a stylized, bold font, with a curved line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a smaller, sans-serif font. The logo is black and white.

K01240S

#### 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: July 2001

#### Device Name:

- Trade Name Extrude Modified .
- Common Name Dental Impression Material •
- Classification Name Impression Material, per 21 CFR § 872.3660 .

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

- Kerr Corporation, Extrude .
#### Device Description:

Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for all crown and bridge, edentulous and implant impression techniques. Extrude Modified is a two-part, base/catalyst - paste/paste system. The two-part system is packaged either in tubes or cartridges. The product is available in three viscosities, Wash, Medium and Extra.

#### Intended Use of the Device:

Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for all crown and bridge, edentulous and implant impression techniques.

#### Substantial Equivalence:

Extrude Modified is substantially equivalent to other legally marketed devices in the United States. Extrude Modified functions in a manner similar to and is intended for the same use as the original as Extrude formulation that is currently manufactured by Kerr Corporation.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 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 a stylized image of three overlapping human profiles facing to the right.

SEP - 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen Boswell Director of Corporation Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue 92667 Orange, California

K012405 Re : Extrude Modified Trade/Device Name: Requlation Number: 872.3660 Requlatory Class: II Product Code: ELW Dated: July 26, 2001 Received: July 30, 2001

Ms. Boswell: Dear

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. पुर substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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concerning your device in the Federal Register. Please note: concerning your actro premarket notification submission does this response co your promas might have under sections 531 not afrect any obligation you mages under the Electronic through 542 of the Act 101 acvises or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your 510 m. promalence of your device to a legally Finding of bubbeaneral oggresults in a classification for your marketed predicate device robadevice to proceed to the market.

If you desire specific advice for your device on our labeling If you desire bpoories and additionally 809.10 for in regulacion (ir eldevices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriation 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 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Obtained From the 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

Ulatowski Timo 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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# KO12405

## Section I

## Indications for Use Statement

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

| Applicant: | Kerr Corporation |
|---------------------------|------------------|
| 510(k) Number (if known): | K012405 |
| Device Name: | Extrude Modified |
| Indications For Use: | |

Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for
all crown and bridge, edentulous and implant impression techniques.

| (Division Sign-Off) | Pamela Scott for Susan Runner |
|---------------------|---------------------------------------------------------------------|
| | Division of Dental, Infection Control, and General Hospital Devices |
| 510(k) Number | K012405 |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
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Concurrence of CDRH, Office of Device Evaluation (ODE)

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