FLEXITIME XTREME

K042878 · Heraeus Kulzer, Inc. · ELW · Dec 17, 2004 · Dental

Device Facts

• Record ID: K042878
• Device Name: FLEXITIME XTREME
• Applicant: Heraeus Kulzer, Inc.
• Product Code: ELW · Dental
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

Device Story

Flexitime Xtreme is a polyvinylsiloxane (PVS) silicone impression material. Used by dental professionals in clinical settings to capture precise anatomical details of teeth and oral structures. Material is applied to a dental tray, inserted into the patient's mouth, and allowed to set to create a negative mold. The resulting impression is used by dental laboratories to fabricate crowns, bridges, inlays, and partial dentures. Benefits include high dimensional stability and accuracy for restorative dental procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polyvinylsiloxane (PVS) silicone-based impression material. Two-component system (base and catalyst) for mixing. Formulated for dental impression applications. Class II device (Product Code: ELW).

Indications for Use

Indicated for dental impression procedures including inlay, crown, bridge, edentulous, and partial impressions in patients requiring dental restorative or prosthetic work.

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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Ms. Cheryl V. Zimmerman Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517

Re: K042878

Trade/Device Name: Flexitime Xtreme Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: October 14, 2004 Received: October 25, 2004

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your because mined the device is substantially equivalent (for the referenced above and have and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device nicesure ecomments, or to devices that have been reclassified in accordance with the provisions of / Includinents, of to do Tosmetic Act (Act) that do not require approval of a premarket the readeral I beath I beagh therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls 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 If your dovice is classince to such additional controls. Existing major regulations affecting (1 vir ), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be rounder announcements concerning your device in the Ecderal Register.

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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. or mo rot of any I 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 and insting (s 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), r lyse 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 http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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): K042878

Device Name: Flexitime Xtreme

Indications for Use: Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

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)

Supd Russd
(Division Sign-Off)

( - Cloin Olgh-Oll)
Division of Anesthesiology, General Hospital, Infection of Anesthesiology, Gene

510(k) Number: Y 042878

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