P2 POLYETHER

K030318 · Heraeus Kulzer, Inc. · ELW · Apr 3, 2003 · Dental

Device Facts

• Record ID: K030318
• Device Name: P2 POLYETHER
• Applicant: Heraeus Kulzer, Inc.
• Product Code: ELW · Dental
• Decision Date: Apr 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

P2 Polyether Impression material is used for inlay, onlay, crown & bridge preparations, functional impressions and implant impressions.

Device Story

P2 Polyether Impression Material is a dental impression material used by dentists to capture accurate anatomical details of teeth and oral structures. The material is applied to the patient's mouth to create a negative mold for inlay, onlay, crown, bridge, and implant restorations. It functions as a physical medium for recording dental geometry. The device is used in a clinical dental setting by licensed dental professionals. The resulting impression allows for the fabrication of precise dental prosthetics, benefiting the patient by ensuring proper fit and function of restorative dental work.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polyether-based dental impression material. Class II device under 21 CFR 872.3660. Product code ELW.

Indications for Use

Indicated for dental patients requiring inlay, onlay, crown and bridge preparations, functional impressions, and implant 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)

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

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 caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

APR - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl V. Zimmerman Manager, Ouality Operations & Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517

Re: K030318

Trade/Device Name: P2 Polyether Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: January 29, 2003 Received: January 30, 2003

Dear Ms. Zimmerman:

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.

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

Page 2 - Ms. Cheryl V. Zimmerman

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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) you may obtain. 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 vours.

Susan Gunner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Page_1__of__1_

K030318 510(k) Number (if Known):

Device Name: P2 Polyether Impression Material

Indications For Use:

P2 Polyether Impression material is used for inlay, onlay, crown & bridge preparations, functional impressions and implant impressions.

(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)

Kein Mulvey for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: