FLASH (DIFFERENT MATERIALS)

K120438 · 3M Deutschland GmbH · ELW · May 2, 2012 · Dental

Device Facts

• Record ID: K120438
• Device Name: FLASH (DIFFERENT MATERIALS)
• Applicant: 3M Deutschland GmbH
• Product Code: ELW · Dental
• Decision Date: May 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Flash VPS Impression Materials are indicated to be used for all precision impressions (of e.g .: crown, bridge, inlay and onlay preparations).

Device Story

Flash VPS Impression Materials are two-component (base paste/catalyst) vinyl polysiloxane materials used for dental impressions. Materials are available in various viscosities (light-bodied, heavy-bodied, putty) and set times (regular, super-quick). Designed for use with 3M Garant mixing/dispensing device or 3M Pentamix automatic mixing/dispensing system. Used by dental professionals in clinical settings to capture accurate anatomical structures of teeth for restorative procedures (crowns, bridges, inlays, onlays). Output is a physical impression mold used by dental labs or clinicians to fabricate dental restorations. Benefits include high-precision reproduction of oral structures to ensure proper fit of dental prosthetics.

Clinical Evidence

No clinical data. Biocompatibility testing was performed using standard risk assessment techniques and FDA/internationally recognized guidelines to confirm safety for intended use.

Technological Characteristics

Vinyl polysiloxane (VPS) two-component impression material. Available in light-bodied, heavy-bodied, and putty viscosities. Compatible with Garant manual/dosing dispensers and Pentamix automatic mixing/dispensing systems. Class II device (21 CFR 872.3660).

Indications for Use

Indicated for patients requiring precision dental impressions for crown, bridge, inlay, and onlay preparations.

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

• Future Wash/YPS (K051797)
• Dimension Penta H (K000591)
• 3M ProPlus System (K963766)

Submission Summary (Full Text)

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

# 1/120438

## MAY - 2 2012

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### Submitter

| Company: | 3M Deutschland GmbH |
|-----------------------------------|---------------------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Desi W. Soegiarto,<br>Regulatory Affairs Specialist |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date: | February 10. 2012 |

#### Name of Device

Proprietary Name: ............................................................................................................................................................

Flash Penta™ HB SQ Flash Penta™ HB Q Flash Heavy Body SQ Flash Heavy Body Q Flash Regular Body SQ Flash Regular Body Q Flash Light Body SQ Flash Light Body Q Flash Ultra-Light Body SQ Flash Penta™ Putty

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

| Classification Name: | Impression material |
|----------------------|----------------------------|
| Common Name: | Dental impression material |

#### Predicate Devices

Future Wash/YPS by 3M Deutschland GmbH, Germany ......... K051797 Dimension Penta H by 3M Deutschland GmbH, Germany ....... K000591 3M ProPlus System by 3M ESPE Dental Products, U.S.A. ....... K963766

#### Description for the Premarket Notification

Flash materials 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.

Flash will be available as wash and tray materials. The wash materials will be available in one viscosity (light-bodied), each of them in a regular set and a super-quick set version. The tray materials will be available in two different viscosities (putty and heavy-bodied) in a regular set and a super-quick set version.

As the predicate devices, Flash materials are two component (base paste/catalyst) vinyl polysiloxane impression materials designed either to be used in 3M Deutschland GmbH's mixing, dosing and dispensing device, Garant™, or to automatically be mixed and dispensed in the Pentamix™ device of 3M Deutschland GmbH.

In this 510(k) premarket notification Flash has been compared to the predicate devices with regard to indications for use, physical and mechanical properties, and chemical composition. The comparison for indications for use, performance data, and chemistry shows that Flash is substantially equivalent to the predicate devices.

Biocompatibility testing was carried out. Biocompatibility assessments were developed for Flash using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash materials are biocompatible for its intended use.

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

In summary, it can be concluded that Flash is as substantially equivalent in safety and effectiveness as the predicate devices Future Wash/YPS by 3M Deutschland GmbH, Germany (K051797), Dimension Penta H by 3M Deutschland GmbH, Germany (K000591), and 3M ProPlus System by 3M ESPE Dental Products, U.S.A. (K963766).

#### Indications for Use:

Flash VPS Impression Materials are indicated to be used for all precision impressions (of e.g .: crown, bridge, inlay and onlay preparations).

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M Deutschland GmbH ESPE Platz D-8229 Seefeld GERMANY

Re: K120438

Trade/Device Name: Flash Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: February 10, 2012 Received: February 13, 2012

Dear Dr. Soegiarto:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

MAY - 2 2012

{4}------------------------------------------------

Page 2 - Dr. Soegiarto

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Clintons

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

{5}------------------------------------------------

### Indications for Use

< 120 438

Flash

510(k) Number (if known):

Device Name:

Indications For Use:

Flash VPS Impression Materials are indicated to be used for all precision impressions (of e.g.: crown, bridge, inlay and onlay preparations).

× 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)

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

ใ Page 1 of

510(k) Submission: Flash

--: "