XANTALGIN CRONO

K013336 · Cavex Holland BV · ELW · Oct 29, 2001 · Dental

Device Facts

• Record ID: K013336
• Device Name: XANTALGIN CRONO
• Applicant: Cavex Holland BV
• Product Code: ELW · Dental
• Decision Date: Oct 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Xantalgin Crono is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

Device Story

Xantalgin Crono is an alginate-based dental impression material. It functions as a color-changing indicator to guide the clinician through the impression process: blue when mixed with water; violet at the end of mixing/loading; pink when ready for insertion into the patient's mouth; and white when the setting time is complete. Used by dental professionals in a clinical setting to capture oral anatomy for the subsequent construction of gypsum casts, study models, and orthodontic appliances.

Clinical Evidence

Bench testing only.

Technological Characteristics

Alginate-based dental impression material. Features a color-changing chemical indicator system to signal mixing, loading, insertion, and setting phases. Class II device, product code ELW.

Indications for Use

Indicated for dental patients requiring oral cavity impressions for study models, individual trays, situation models, and orthodontic impressions.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2001

Mr. Richard Woortman Manager Technical Services Cavex Holland B.V. Harmenjansweg 19 P.O. Box 852 Haarlem (Holland) NETHERLANDS

Re: K013336

Trade/Device Name: Xantaglin Crono Regulation Number: 872.3660 Regulation Name: Alginate Impression Material Regulatory Class: II Product Code: ELW Dated: October 8, 2001 Received: October 9, 2001

Dear Mr. Woortman:

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

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mean that FDA has made a determination that your device complies with other requirements modi that I DA mas made a statutes and regulations administered by other Federal agencies. of the Act of ally I outstal statest requirements, including, but not limited to: registration I ou must compry with an are rise Jog (21 CFR Part 801); good manufacturing practice alle listing (21 CF RT rat 007), acclines (QS) regulation (21 CFR Part 820); and if requirences as set form in als quality ijo 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 I his letter will anow you to begin in the may of substantial equivalence of your device to 310(k) promation nounce 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 If you desire up con of 2001 of r in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Collightance itse, 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 nonicallor (21 OF ICP of the Division of Small Manufacturers, International and the Act may be counter its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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K013336

510(k) NUMBER (IF KNOWN): KO/3336

DEVICE NAME: Xantalgin Crono Alginate Impression Materials

INDICATIONS FOR USE:

Xantalgin Crono is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

Xantalgin Crono has the special characteristic of being a color-changing alginate: it becomes blue upon contact with water in the mixing bowl. It changes to violet indicating the end of the mixing time and loading the tray. Then it changes to pink indicating the moment to insert the tray into the mouth of the patient and finally it changes to white indicating the end of the setting time in the mouth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription UseV (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

Sudar Runner

(Division Sign-Off) (Division Sign-Onn)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Dontonital Devic 510(k) Number -