FUTURABOND M/FUTURABOND M SINGLE DOSE

K082753 · Voco GmbH · KLE · Nov 24, 2008 · Dental

Device Facts

• Record ID: K082753
• Device Name: FUTURABOND M/FUTURABOND M SINGLE DOSE
• Applicant: Voco GmbH
• Product Code: KLE · Dental
• Decision Date: Nov 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes, Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations, Futurabond M/Futurabond M Single Dose is also suited for the treatment of exposed root surfaces, Futurabond M/Futurabond M Single Dose can be used for core build-ups using light-cured or dual-cured filling materials.

Device Story

Futurabond M/Futurabond M Single Dose is a single-component, light-curing, self-etch dental bonding agent reinforced with nano-particles. It is used by dental professionals to create a durable bond between tooth substance and light-curing filling materials, composites, compomers, and Ormocer®s. The device eliminates the need for separate tooth etching, tolerates residual moisture, and prevents marginal leakage. It is supplied in 5 ml plastic bottles or 0.06 ml single-dose blisters. The adhesive is applied to the tooth surface and light-cured to facilitate restorative procedures, including direct restorations, cavity sealing, root surface treatment, and core build-ups. By providing a reliable bond, it aids in the structural integrity and longevity of dental restorations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the prior use of components in legally marketed devices and performance data supporting safety and effectiveness.

Technological Characteristics

Single-component, light-curing, self-etch dental adhesive; contains nano-particles; supplied in plastic bottles or single-dose blisters; compatible with light-curing composites, compomers, and Ormocer®s; tolerates residual moisture.

Indications for Use

Indicated for patients requiring dental adhesive for direct restorations (all cavity classes), cavity sealing for indirect restorations, treatment of exposed root surfaces, and core build-ups using light-cured or dual-cured filling materials.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• Clearfil S³Bond (K042913)
• Clearfil S³Bond Single Dose (K051796)

Reference Devices

• Xeno Adhesive with Activator (K051463)

Submission Summary (Full Text)

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K082753

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Anton-Flettner-Straße 1 - 3 27472 Cuxhaven · Germany

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NOV 24 2008

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VOCQ GmbH · Postfach 7 67 · 27457 Cuxhaven · Germany

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Datum date

## 510(k) SUMMARY

Manfred Th. Plaumann

Contact:

September 10, 2008 Date prepared:

Futurabond M/Futurabond M Single Dose Trade or proprietary name:

Agent, Tooth Bonding Resin (872.3200) Classification name:

| Predicate devices: | Clearfil S³Bond | K042913 |
|--------------------|-----------------------------|---------|
| Predicate devices: | Clearfil S³Bond Single Dose | K051796 |

Device description: Futurabond M/Futurabond M Single Dose is a single-component, light-curing, self-etch-bond reinforced with nano-particles to build a durable bond between tooth substance and light-curing filling materials without marginal leakage.

Futurabond M/Futurabond M Single Dose displays the same adhesive properties of totaletch preparations without separate etching of the tooth substance.

Futurabond M/Futurabond M Single Dose tolerates residual moisture.

Futurabond M/Futurabond M Single Dose is an all-purpose adhesive for use with all lightcuring composites, compomers and Ormocer®s.

Futurabond M/Futurabond M Single Dose is offered in 5 ml plastic bottles (Futurabond M) and in 0.06 ml Single Dose blisters (Futurabond M Single Dose).

## Intended use:

- Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes,
- Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations
- Futurabond M/Futurabond M Single Dose is also suited for the treatment of . exposed root surfaces
- Futurabond M/Futurabond M Single Dose can be used for core build-ups using . light-cured or dual-cured filling materials.

Geschältslüher: Martied Plaunan, Martied Thonas Plaunan, Olaf Sauerbier / Antsgericht Tosted HFB 110134 - Eritillungson und Gerichtsstand: Cushaven Stadisparkasse Cuxhaven (BLZ 241 500 01) 149690 · IBAN: DE942415000100001496900 BIC: BHLMDE21CUX

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Technological characteristics: All of the components of Futurabond M/Futurabond M Single Dose are found in the legally marketed devices K042913 (Clearfil S3Bond), M0176 (Clearfil S Bond Single Dose) and K051463 (Xeno Adhesive with Activator) Futurabond M and Futurabond M Single Dose are identical in composition and performance characteristics.

The prior use of all of the components of Futurabond M/Futurabond M Single Dose in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.

We believe that the prior use of the components of Futurabond M/Futurabond M Single Dose in legally marketed devices and the performance data and results provided support the safety and effectiveness of Futurabond M/Futurabond M Single Dose for the intended use.

VOCO GmbH September 10, 2008

GMBIF
Manfred Th. Plaumanion-Flettner-Str. 1-3
(Managing Board) 27472 CUXHAVEN

Germany

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the seal is an abstract emblem that resembles an eagle or bird-like figure with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Thorsten Gerkensmeier VOCO GmbH Anton-Flettner-Strasse 1-3 Cuxhaven, Germany D- 27472 NOV 2 4 2008

Re: K082753

> Trade/Device Name: Futurabond M/Furabond M Single Dose Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 17, 2008 Received: September 19, 2008

Dear Dr. Gerkensmeier:

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 - Dr. Gerkensmeier

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other seneral 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.

Smite Y. Michael Dms.

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use Statement

1087753 510(k) Number:

Device Name: Futurabond M/Futurabond M Single Dose

Indications for Use:

- Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes.
- Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations
- Futurabond M/Futurabond M Single Dose is also suited for the treatment of exposed root surfaces
- Futurabond M/Futurabond M Single Dose can be used for core build-ups using light-cured or dual-cured filling materials.

Prescription Use

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runn

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

510(k) Number: IC082753