KROMATICA COLOR CHANGING ALGINATE

K974894 · Matech, Inc. · ELW · Feb 12, 1998 · Dental

Device Facts

• Record ID: K974894
• Device Name: KROMATICA COLOR CHANGING ALGINATE
• Applicant: Matech, Inc.
• Product Code: ELW · Dental
• Decision Date: Feb 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

This material is to be used by the dentist to produce an impression of a person's mouth/teeth and then a plaster material is poured into this impression to create a cast of the patient's mouth/ teeth.

Device Story

Kromatica Alginate Impression Material is a dental impression material used by dentists to capture the anatomy of a patient's mouth and teeth. The material is mixed and placed in an impression tray, inserted into the patient's mouth, and allowed to set. Once set, the impression is removed, and a plaster material is poured into the mold to create a physical cast of the patient's dentition. The device facilitates the creation of dental models for diagnostic or restorative purposes. It is a manual, non-electronic dental material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Alginate-based dental impression material. Formulated as a powder for mixing with water to form a gel. Color-changing property indicates setting stages. Class II medical device.

Indications for Use

Indicated for use by dentists to create dental impressions of a patient's mouth and teeth for the subsequent fabrication of dental casts.

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul L. Saxton Manaqer Matech, Incorporated 13010 San Fernando Road Sylmar, California 91342

FEB 1 2 1998

K974894 Re : Kromatica Color Changing Alginate Trade Name: Regulatory Class: II Product Code: ELW December 12, 1997 Dated: Received: December 31, 1997

Dear Mr. Saxton:

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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Saxton

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, 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 finding of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. 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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510(k) Number (if known):

Device Name: Kromatica Alginate Impression Material

Matech, Inc. 510 (k) Request. Indications For Use:

> The Intended Use: This material is to be used by the dentist to produce an impression of a person's mouth/teeth and then a plaster material is poured into this impression to create a cast of the patient's mouth/ teeth.

> > Sincerely,

Paul L. Saxton

Manager Matech, Inc. 13010 San Fernando Road Sylmar, CA 91342

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Turner
(Division Chief)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)