ZETAPLUS SOFT by ZHERMACK S.P.A.

Zhermack ZETAPLUS SOFT a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. ZETAPLUS SOFT is material for preliminary impression (first impression).

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for the Zetaplus Soft dental impression material does not contain the detailed information requested regarding acceptance criteria and study data.

The document is a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices. It provides:

Trade/Device Name: Zetaplus Soft
Regulation Number and Name: 872.3660, Impression Material
Regulation Class: II
Product Code: ELW
Indications for Use: "Zhermack ZETAPLUS SOFT a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. ZETAPLUS SOFT is material for preliminary impression (first impression)."

However, it does not include any studies, performance data, or acceptance criteria in the format requested. These details would typically be found in the 510(k) submission itself, which is a much larger technical document not included in this clearance letter.

Therefore, I cannot populate the table or answer the specific questions about the study from the provided text.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Zhermack S. P. A. C/O Mr. Gerald W. Shipps Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702

Re: K024041

Trade/Device Name: Zetaplus Soft Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 2, 2002 Received: December 6. 2002

Dear Mr. Shipps:

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. Shipps

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). please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Pelloux Cucute fils

Timothy A. Ulatowski 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 Statement

510(k) Number:

ZETAPLUS SOFT

240

Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Surser Rume

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

510(k) Number K093211

Regulation Number and Section

§ 872.3660 Impression material.

(a)
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.(b)
Classification. Class II (Special Controls).