EMULATE FAST SET AND EMULATE REGULAR SET

K020242 · Cavex Holland BV · ELW · Apr 17, 2002 · Dental

Device Facts

• Record ID: K020242
• Device Name: EMULATE FAST SET AND EMULATE REGULAR SET
• Applicant: Cavex Holland BV
• Product Code: ELW · Dental
• Decision Date: Apr 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

emulate Fast Set and emulate Regular Set are dental impression materials based on emmate Fast Set and emailate Nogains of the oral cavity with the purpose of alginate. They are are about for taxing in the situation in the mouth. They are constructing a gypoum odot that evials for making study models, first impressions for general purpose improolor. maters, situation models, orthodontic impressions etc.

Device Story

Emulate Fast Set and Regular Set are alginate-based dental impression materials. Used by dental professionals to capture negative replicas of the oral cavity. Material is mixed and placed in an impression tray, inserted into the patient's mouth, and allowed to set. Once hardened, the impression is removed and used to create a positive gypsum model. Facilitates clinical workflows for study models, orthodontic planning, and general dental diagnostics. Benefits include accurate anatomical reproduction for treatment planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Alginate-based dental impression material. Supplied as a powder for mixing with water. Sets via chemical reaction to form a hydrocolloid gel. Class II device (Product Code: ELW).

Indications for Use

Indicated for dental patients requiring oral cavity impressions for the construction of gypsum study models, first impressions for general purpose, 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850

# APR 1 7 2002

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

Re: K020242

Trade/Device Name: Emulate Fast Set & Emulate Regular Set Regulation Number: 872.3660 Regulation Name: Alginate Impression Material Regulatory Class: II Product Code: ELW Dated: January 18, 2002 Received: January 23, 2002

#### 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. Woortman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and 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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Ko20242

NUMBER (IF KNOWN) : 510 (k)

## DEVICE NAME : emulate Fast Set & emulate Regular Set Alginate Impression Materials

INDICATIONS FOR USE:

emulate Fast Set and emulate Regular Set are dental impression materials based on emmate Fast Set and emailate Nogains of the oral cavity with the purpose of alginate. They are are about for taxing in the situation in the mouth. They are constructing a gypoum odot that evials for making study models, first impressions for general purpose improolor. maters, situation models, orthodontic impressions etc.

(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)

Susan Rumm

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