ELITE IMPLANT

K050417 · Zhermack S.P.A. · ELW · Jul 19, 2005 · Dental

Device Facts

• Record ID: K050417
• Device Name: ELITE IMPLANT
• Applicant: Zhermack S.P.A.
• Product Code: ELW · Dental
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

ELITE IMPLANT is a radiopaque dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a dental patient's teeth. Additionally, it is intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and onlays. Its radiopacity is intended to assist in detecting possible fragments of residual material.

Device Story

Elite Implant is a radiopaque dental impression material. Clinician places material on preformed impression tray; applies to patient's teeth to capture structural anatomy. Material hardens to create negative impression; used to produce dental models for study or fabrication of restorative prosthetics like inlays and onlays. Radiopacity allows clinicians to identify and remove residual material fragments post-procedure. Used in dental clinic settings by dental professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiopaque dental impression material. Formulated for use with preformed impression trays. Class II device (Product Code: ELW).

Indications for Use

Indicated for dental patients requiring impressions for study models or restorative prosthetic devices (inlays/onlays).

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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JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ZHERMACK S.P.A. c/o Mr. Gerald W. Shipps, Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend. Oregon 97702

Re: K050417

Trade/Device Name: Elite Implant Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: II Product Code: ELW Dated: June 08, 2005 Received: June 09, 2005

Dear Mr. Shipps:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed four beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enates, 1976, the enactment date of the Medical Device Amendments, or to conimered provision of ridge in accordance with the provisions of the Federal Food, Drug, de nees that have been that do not require approval of a premarket approval application (PMA). and Cosmetter For (110) and the device, subject to the general controls provisions of the Act. The I ou may, cherefore, mains of the Act include requirements for annual registration, listing of general controll profice, 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 If your device is elaboried (see as coltrols. Existing major regulations affecting your device can may be subject to back access 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. Shipps

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s lossantes or our device complies with other requirements of the Act that TDA has made a dolorimiations administered by other Federal agencies. You must of any reach statutes and regarments, including, but not limited to: registration and listing (21 comply with an the 10th strequirements, and manufacturing practice requirements as set CFK Fart 807), labeling (21 OF R Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Seting your device as described in your Section 510(k) I mis letter will anow you to begin mailiering of substantial equivalence of your device to a legally premarket notification: The PDF imaling 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 acries is. Jose [phone]. Also, please note the regulation entitled, Colliact the Office of Complanse in (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on your response at its toll-free number [phone] or Manufacturers, International and Occess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Quls

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

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## Indications for Use

··

510(k) Number (if known): K050417

Device Name: ELITE IMPLANT

Indications for Use:

ELITE IMPLANT is a radiopaque dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a dental patient's teeth. Additionally, it is intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and onlays. Its radiopacity is intended to assist in detecting possible fragments of residual material.

×

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

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

تحت ترته بعد به

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rsbete DDS for Dr. S. Runner

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

510(k) Number:

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