CAVEX ORTHOTRACE

K051207 · Cavex Holland BV · ELW · Jun 21, 2005 · Dental

Device Facts

• Record ID: K051207
• Device Name: CAVEX ORTHOTRACE
• Applicant: Cavex Holland BV
• Product Code: ELW · Dental
• Decision Date: Jun 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Cavex Orthotrace alginate impression material is a dental impression material based on alginate. It is a material that is used for taking impressions of the oral cavity with the purpose of constituting a gypsum cast that is a copy of the situation in the mouth. Cavex Orthotrace has an extra fast setting and is a high elasticity, high tear resistance, can be poured twice with gypsum and is proven in an attractive fuchsia-coloured powder source. Orthotrace is particularly suited for orthodontics.

Device Story

Cavex Orthotrace is an alginate-based dental impression material. It is supplied as a fuchsia-colored powder that is mixed to create a paste for taking impressions of the oral cavity. The material features extra-fast setting, high elasticity, and high tear resistance. It allows for double-pouring with gypsum to create accurate casts of the oral anatomy. Used by dental professionals, particularly in orthodontic settings, to capture the patient's oral situation for diagnostic or treatment planning models.

Clinical Evidence

No clinical data provided. The device is a standard dental impression material; substantial equivalence is based on established material properties and intended use.

Technological Characteristics

Alginate-based dental impression material. Features include extra-fast setting, high elasticity, and high tear resistance. Form factor is a powder for mixing. No electronic components or software.

Indications for Use

Indicated for taking dental impressions of the oral cavity to create gypsum casts for orthodontic purposes.

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

JUN 2 1 2005

Mr. Richard Woortman Manager, Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem THE NETHERLANDS

Re: K051207

Trade/Device Name: Cavex Orthotrace Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 02, 2005 Received: May 11, 2005

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.

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## Page 2 -- Mr. Richard Woortman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1727 s issualled of a subscription with other requirements of the Act or that FDA nas made a decemination allar your as your Federal agencies. You must comply with any Pederal Statutes and regulations administered of taxistration and listing (21 CFR Part 807); all the Act s requirements, merading, but virus ments as set forth in the quality labeling (21 CFR 1 art 801); good manazations of applicable, the electronic product radiation systems (QB) rogalisons 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) This letter will anow you to oegin maing of substantial equivalence of your device to a legally premarked notheation: "The PDF mining sification 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), please If you desire specific acrite int 70% [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other Misoranianing of relerence to promobilities under the Act from the Division of Small general international on your consumer Assistance at its toll-free number [phone] or Manufacturers, International and Oction http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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510(k) NUMBER (IF KNOWN):

DEVICE NAME: Cavex Orthotrace Alginate impression material

INDICATIONS FOR USE:

Cavex Orthotrace alginate impression material is a dental impression material based Gavex Ofthotraos alginate inity impressions of the oral cavity with the purpose of on algmate. It is aboution that is a copy of the situation in the mouth. Cavex constitucing a gypoum oact that is atisf, high elasticity, high tear resistance, can be Orthotrace has an oxtra fact betting and in a attractive fuchsia-coloured powder pource twice with gypount and is proven Orthotrace is particularly suited for orthodontics

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

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

Koin Muluy for MSR

Division of Anesthesiology. Gene

510(k) Number: