CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL

K041028 · Crown Delta Corp. · ELW · May 14, 2004 · Dental

Device Facts

• Record ID: K041028
• Device Name: CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
• Applicant: Crown Delta Corp.
• Product Code: ELW · Dental
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Crown Delta's Hydrophilic vinyl polysiloxane impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production inflorotive of the testic devices. The impression material is intended to be applied via a dual be rooterative prosem either into an impression tray or directly onto the patient's teeth. The "hydrophilic" enhancement will enable production of more accurate impression when adverse conditions (e.g. the presence of blood or saliva) are present.

Device Story

Crown Delta Hydrophilic Impression Material is a vinyl polysiloxane (VPS) dental impression material; used by dentists to create accurate molds of teeth and gums. Material applied via dual-barrel dispenser into impression trays or directly onto oral tissues. Hydrophilic properties improve accuracy in presence of moisture, blood, or saliva. Output is a physical dental impression used for study models or fabrication of restorative devices. Device is a consumable dental material used in clinical settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Vinyl polysiloxane (VPS) impression material; hydrophilic formulation; dual-barrel delivery system; physical impression material for dental use.

Indications for Use

Indicated for patients requiring dental impressions for study models or restorative devices. Used by dental professionals to capture teeth and gum anatomy, including in the presence of blood or saliva.

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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is simple and recognizable, conveying the department's role in public health and welfare.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2004

Mr. Mark P. Konopka Manager of Regulatory Affairs Crown Delta Corporation 1550 Front Street Yorktown Heights, New York 10598

Re: K041028

Trade/Device Name: Crown Delta Hydrophilic Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: April 20, 2004 Received: April 21, 2004

Dear Mr. Konopka:

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, I DA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page 2 -Mr. Konopka

Please be advised that FDA's issuance of a substantial equivalence determination does not I toase of act race a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rever any 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 uncilling (2) roquirents as as roonic 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) I mo letter notification. The FDA finding of substantial equivalence of your device to a premaired predicated. - I a 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), n 130 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

Sincerely yours,

Clue

Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known):_KO41078

Device Name: Crown Delta Hydrophilic Impression Material

## Indications for Use:

Crown Delta's Hydrophilic vinyl polysiloxane impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production inflorotive of the testic devices. The impression material is intended to be applied via a dual be rooterative prosem either into an impression tray or directly onto the patient's teeth. The "hydrophilic" enhancement will enable production of more accurate impression when adverse conditions (e.g. the presence of blood or saliva) are present.

Prescription Use / AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Supe

sthesiology, General Hospital,

510(k) Number: K041027

Page 1 of 1