FLEXITIME FLOW

K091494 · Heraeus Kulzer, Inc. · ELW · Jul 31, 2009 · Dental

Device Facts

• Record ID: K091494
• Device Name: FLEXITIME FLOW
• Applicant: Heraeus Kulzer, Inc.
• Product Code: ELW · Dental
• Decision Date: Jul 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Flexitime Light Flow/Flexitime Medium Flow each is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.

Device Story

Flexitime Flow is a polyvinyl siloxane (PVS) dental impression material used by dental professionals in clinical settings. It functions as an addition-cross-linking material to capture precise anatomical details of teeth and oral structures. The material is applied to the patient's mouth to create impressions for inlays, crowns, bridges, and partial or edentulous restorations. The resulting impression serves as a physical mold, allowing the dentist to fabricate accurate dental prosthetics. The device benefits patients by ensuring high-fidelity fit and function of restorative dental work.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Addition-cross-linking polyvinyl siloxane impression material. Class II dental impression material (21 CFR 872.3660). Product code ELW.

Indications for Use

Indicated for use as an addition-cross-linking polyvinyl siloxane impression material for dental procedures including inlay, crown and bridge, edentulous, and partial 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).

Predicate Devices

• Flexitime Magnum 360 (K000629)
• Flexitime Magnum 360 (K003930)

Submission Summary (Full Text)

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

K091494

Heraeus Kulzer, LLC Product Name: Flexitime Light Flow / Medium Flow 510(k) Pre-Market Notification Submission

## GENERAL INFORMATION

May 12, 2009

Cheryl V. Zimmerman Submitter: 300 Heraeus Wav South Bend, Indiana 46614

JUL 8 1 2009

Telephone No.: 574-299-5444

Date:

574-291-2542 Fax No .:

Submitter's Company Establishment Number: 1925223

Submitter's Company Name: Heraeus Kulzer, LLC

Device Trade Name: Flexitime Flow

Device Common Name: Dental Impression Material

Original 510(k) No.: Not Applicable

Manufacturer: Heraeus Kulzer. GmbH Hanau, Germany

Device Classification: Class II - Dental Impression Material. 21 CFR Part 872.3660

Device Product Code: 76ELW

Reason for Submission: This submission is being made to request approval to market Flexitime Flow.

Statement of Substantial Equivalence: Flexitime Light Flow /Medium Flow is equivalent to Flexitme Magnum 360 K000629 and K003930.

Compliance with requirements of Performance Standards: No performance standards have been established for this type of device. The results of device performance testing demonstrated that it is suitable for use as an impression material, Flexitime Flow has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.

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

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

## BOOZ I 8 THET

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl V. Zimmerman Manager. Quality Operations and Compliance Heraeus Kulzer, Incorporated 300 Heraeus Way South Bend, Indiana 46614

Re: K091494

Trade/Device Name: Flexitime Light Flow and Flexitime Medium Flow Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 15, 2009 Received: May 20, 2009

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 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.

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

Page 2- Ms. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Susan Runner

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page 1 of 1

510(k) Number (if Known):

Device Name: Flexitime Light Flow / Medium Flow

Indications For Use:

1. 1. 1.

Flexitime Light Flow/Flexitime Medium Flow each is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.

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

Concurrence of CDRH, Office of Device evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | V |
|------------------------------------------|----------------------|
| OR | Over-The-Counter Use |

| (Division Sign-Off) | Rin Mulby for MSR (Optional Format 1-2-96) |
|-----------------------------------------------------------------------------------|--------------------------------------------|
| Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| 510(k) Number: | R091494 |