FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS

K081120 · Kettenbach GmbH & Co. KG · ELW · May 1, 2008 · Dental

Device Facts

• Record ID: K081120
• Device Name: FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS
• Applicant: Kettenbach GmbH & Co. KG
• Product Code: ELW · Dental
• Decision Date: May 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials are intended for making accurate occlusal records.

Device Story

Futar bite registration materials are syringeable, addition-curing, elastomeric silicones used by dental professionals to capture occlusal records. The product line includes variants with differing hardness levels and working times (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan). Futar Scan is specifically formulated for optical scanning in CAD/CAM/CIM workflows, eliminating the need for contrast powder. The materials are applied intraorally to record the patient's bite; the resulting physical impression or optical data is used by clinicians to facilitate restorative or diagnostic dental procedures. The device benefits patients by ensuring accurate alignment and fit of dental restorations.

Clinical Evidence

Bench testing only. The device was evaluated against criteria in FDA Guidance for Industry and FDA Staff: Dental Impression Materials (FOD#2203), ISO 4823 (Dentistry – Elastomeric impression materials), and DIN 13903 (Dentistry-Bite registration material). No clinical data was required or provided.

Technological Characteristics

Addition-curing elastomeric silicone materials. Syringeable form factor. Designed for manual application. Compliant with ISO 4823 and DIN 13903 standards. No electronic components or software.

Indications for Use

Indicated for making accurate occlusal registrations. Futar D variants are indicated for applications requiring hard bite registration silicone. Futar D Fast is indicated for small applications requiring shorter working time; Futar D Slow is indicated for time-consuming registrations requiring longer working time. Futar Scan is indicated for optical registration of occlusal data for CAD/CAM/CIM systems without powder.

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

• Futar® Occlusion, Futar® D Occlusion (K954281)
• R-SI-LINE® METAL-BITE® (K010926)
• Mega Bite Registration (K030776)

Submission Summary (Full Text)

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Traditional Premarket Notification [510(k)] Futar® Bite Registration Materials

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## 510(K) Summary

MAY - 1 2008

A. Submitter Information Submitter's Name: Address:

Phone Number:

Contact Person:

Date of Preparation:

Fax Number:

Kettenbach GmbH & Co. KG Im Heerfeld 7 D-35713 Eschenburg, Germany ([phone] ([phone] Michaela Zinke March 27, 2008

- B. Device Name
Trade Name:

Common/Usual Name: Classification Name:

Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials Bite Registration Material Material, Impression (21 CFR 827.3660, Product Code: ELW)

- C. Predicate Devices Trade Name: Trade Name: Trade Name:
Futar® Occlusion, Futar® D Occlusion (K954281) R-SI-LINE® METAL-BITE® (K010926) Mega Bite Registration (K030776)

- D. Device Description
Futar®, Futar® D, Futar® D Fast, Futar® D Slow, and Futar® Scan are syringeable, addition-curing, elastomeric bite registration materials which differ in their final hardnesses, curing times, and linear dimensional changes.

.

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- E. Intended Use
Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials are intended for making accurate occlusal records. S

#### Indications for Use

- All Futar bite registration materials (Futar, Futar D, Futar D Fast, Futar D Slow, . Futar Scan) can be used for making accurate occlusal registrations.
- Futar D materials (Futar D, Futar D Fast, Futar D Slow) can be used for . applications, which require a hard bite registration silicone.
- Futar D Fast can be used for "small applications" because of its shorter working . time.
- Futar D Slow can be used for time-consuming bite registrations because of its . longer working time.
- Futar Scan can also be used for an optical registration of occlusal data for . CAD/CAM/CIM systems without using powder.

# F. Technological Characteristics Summary

The technological characteristics of Futar® (Futar® D, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials are substantially equivalent to the predicate device technological characteristics. Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) and the predicate devices are syringeable, addition-curing, elastomeric materials designed and manufactured for use as bite registration materials.

#### G. Performance Data

No performance standards have been established for this type of device. Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998), ISO 4823 (Dentistry – Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007, and DIN 13903:2005 (Dentistry-Bite registration material). The results of device performance testing demonstrated that

## Kettenbach GmbH & Co. KG

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Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) are suitable for use as bite registration materials. Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) Bite Registration Materials have been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kettenbach GmbH & Company KG C/O Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America Incorporated 1775 Old Highway 8 NW, Suite 104

New Brighton, Minnesota 55112-1891

Re: K081120

Trade/Device Name: Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: April 18, 2008 Received: April 21, 2008

Dear Mr. Preiss:

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.

MAY - 1 2008

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Page 2 - Mr. Preiss

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 [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/industry/support/index.html.

Sincerely yours,

Snytte Y. Michau Davis

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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Traditional Premarket Notification [510(k)] Futar® Bite Registration Materials

# SECTION I-D

# Indications for Use

510(k) Number (if known): KO 8 1 20

Device Name: Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials

Indications for Use:

- All Futar bite registration materials (Futar, Futar D, Futar D Fast, Futar D Slow, . Futar Scan) can be used for making accurate occlusal registrations.
- Futar D materials (Futar D, Futar D Fast, Futar D Slow) can be used for . applications, which require a hard bite registration silicone.
- Futar D Fast can be used for "small applications" because of its shorter working . time.
- Futar D Slow can be used for time-consuming bite registrations because of its . longer working time.
- Futar Scan can also be used for an optical registration of occlusal data for CAD/CAM/CIM systems without using powder.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Rame

(Division Sign-Off) Page 1 of 1 Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Kettenbach GmbH & Co. KG

510(k) Number: K0811

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