FUTURE WASH/YPS

K051797 · 3M Espe AG Dental Products · ELW · Jul 21, 2005 · Dental

Device Facts

• Record ID: K051797
• Device Name: FUTURE WASH/YPS
• Applicant: 3M Espe AG Dental Products
• Product Code: ELW · Dental
• Decision Date: Jul 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Indications for Use

Future Wash (Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step): Wash material for all kinds of dual phase impression techniques. YPS (YPS Penta™ HB Quick Step): Tray material for all kinds of dual phase impression techniques.

Device Story

Future Wash and YPS are two-component (base/catalyst) silicone dental impression materials. Future Wash (light/regular body) is used as a wash material; YPS Penta HB Quick Step is used as a tray material. Future Wash is dispensed via the Garant mixing/dosing device; YPS is mixed and dispensed via the Pentamix 2 device. Used by dental professionals in clinical settings to create accurate dental impressions for restorative procedures. The materials harden to capture the structure of a patient's teeth, facilitating the fabrication of dental prosthetics.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed to demonstrate safety. Performance characteristics were compared to predicate devices to demonstrate effectiveness.

Technological Characteristics

Two-component silicone impression material (base/catalyst). Available in light and regular viscosities with regular-set and quick-set options. Dispensed via mechanical mixing systems (Garant or Pentamix 2). Class II medical device.

Indications for Use

Indicated for use as dental impression materials in dual-phase impression techniques for the reproduction of tooth structures.

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

• Dimension™ Garant™ L (K000588)
• Dimension™ Penta™ H (K000591)

Submission Summary (Full Text)

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:

# 1205 1797

## JUL 2 1 2005

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter | |
|------------------------------------|------------------------------------------------------|
| Company: | 3M ESPE AG |
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann,<br>Manager Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| Date: | July 1, 2005 |

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#### Name of Device

| Proprietary Name: | Future Wash Light Body |
|-------------------|-------------------------------------|
| | Future Wash Light Body Quick Step |
| | Future Wash Regular Body |
| | Future Wash Regular Body Quick Step |
| | YPS Penta™ HB Quick Step |

Impression material

Common Name: Dental impression material

#### Predicate Devices:

Classification Name

Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step:

Dimension™ Garant™ L, K000588

YPS Penta HB Quick Step:

Dimension™ Penta™ H, K000591

#### Description for the Premarket Notification

Future Wash and YPS are classified as Impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth.

Future Wash will be available as wash material in two different viscosities (light body, regular body), each of them in a regular-sct and a quick-set version, and YPS will be a tray material in a quick-set version.

3M ESPE is submitting this special 510(k) for modifications to its silicone impression materials Dimension™ Garant™ L and Dimension™ Penta™ H.

The Future Wash materials are two component (base paste/catalyst) materials designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™. YPS is a two

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component (base paste/catalyst) materials to automatically be mixed and dispensed in the 3M ESPE's Pentamix™ 2 device.

To provide evidence for safety biocompatibility testing was carried out. The results show that Future Wash and YPS are safe devices.

To prove the effectiveness of Future Wash and YPS, their performance characteristics were compared to those of the respective predicate devices.

In summary, Future Wash and YPS, described in this 510(k) premarket notification submission, are, in our opinion, substantially equivalent to the respective predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized representation of three human profiles facing right, arranged in a vertical stack. The profiles are connected by a flowing line that suggests movement or progress. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2005

Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY

Re: K051797

Trade/Device Name: Future Wash and YPS PentaTM Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 01, 2005 Received: July 05, 2005

Dear Dr. Petermann:

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. Andreas Petermann

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" (21 CFR 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 vours.

Chiu S. Lin, PhD

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): L051797

Device Name: Future Wash (Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step)

YPS (YPS Penta™ HB Quick Step)

Indications For Use:

Future Wash (Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step): Wash material for all kinds of dual phase impression techniques.

YPS (YPS Penta™ HB Quick Step): Tray material for all kinds of dual phase impression techniques.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Seter DDS for Dr. Susan Runner

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510(k) Number