FLASH AR PENTA / FLASH AR PENTA QUICK

K131404 · 3M Deutschland GmbH · ELW · May 30, 2013 · Dental

Device Facts

• Record ID: K131404
• Device Name: FLASH AR PENTA / FLASH AR PENTA QUICK
• Applicant: 3M Deutschland GmbH
• Product Code: ELW · Dental
• Decision Date: May 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Impressions for the production of temporary restorations All types of preliminary impressions . Impressions of the opposing jaw . Impressions for orthodontic models .

Device Story

Flash AR Penta and Flash AR Penta Quick are medium-bodied (ISO Type 2) vinyl polysiloxane (A-silicone) dental impression materials. The device consists of a two-component system (base paste and catalyst) designed for automatic mixing and dispensing via 3M Pentamix devices. The material is used by dental professionals in a clinical setting to capture the structure of a patient's teeth. The resulting impression serves as a physical model for temporary restorations, orthodontic planning, or opposing jaw records. The device is a manual, non-electronic material system; it does not involve digital processing or clinical decision-making algorithms.

Clinical Evidence

No clinical data. Biocompatibility testing was performed in accordance with FDA and internationally recognized guidelines, confirming the materials are biocompatible for their intended use.

Technological Characteristics

Medium-bodied (ISO Type 2) vinyl polysiloxane (A-silicone) impression material. Two-component system (base paste/catalyst) with a 5:1 mixing ratio by volume. Designed for use with Pentamix automatic mixing and dispensing systems. Biocompatible formulation.

Indications for Use

Indicated for dental patients requiring preliminary impressions, impressions of the opposing jaw, impressions for orthodontic models, or impressions for the production of temporary restorations.

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

• Position Penta™ & Position Penta™ Quick (K974231)
• Flash (K120438)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## MAY 3 0 2013

#### 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: | March 06, 2013 |

#### Name of Devices

| Proprietary Name: | Flash AR Penta™ |
|----------------------|----------------------------|
| Classification Name: | Impression material |
| Common Name: | Dental impression material |

#### Predicate Devices

:

| Position Penta ^TM & Position Penta ^TM Quick | |
|-------------------------------------------------------------------|---------|
| by 3M Deutschland GmbH, Germany | K974231 |
| Flash | |
| by 3M Deutschland GmbH, Germany | K120438 |

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### Description for the Premarket Notification

Flash AR Penta™ and Flash AR Penta™ Quick 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 AR Penta™ and Flash AR Penta™ Quick have been developed based on Position Penta™ and Position Penta™ Quick of 3M Deutschland GmbH (K974231), predicate devices to which Flash AR Penta™ and Flash AR Penta™ Quick have been compared. As the predicate devices Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 5:1 (by volume).

In this 510(k) premarket notification Flash AR Penta™ and Flash AR Penta™ Quick have 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 AR Penta™ and Flash AR Penta™ Quick are substantially equivalent to the predicate devices.

Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Flash AR Penta™ and Flash AR Penta™ Quick in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash AR Penta™ and Flash AR Penta™ Quick materials are biocompatible for its intended use.

In summary, it can be concluded that Flash AR Penta™ and Flash AR Penta™ Quick are as substantially equivalent in safety and effectiveness as the predicate devices Position Penta™ & Position Penta™ Quick by 3M Deutschland GmbH, Germany (K974231) and Flash materials by 3M Deutschland GmbH, Germany (K120438).

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## Indications for Use:

- · Impressions for the production of temporary restorations
- All types of preliminary impressions .
- Impressions of the opposing jaw .
- Impressions for orthodontic models .

5 10(k) Submission: Flash AR Penta & Flash AR Penta Quick; March 06, 2013

,

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three intertwined strands and a base resembling a wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

#### Public Health Service

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

#### May 30, 2013

3M Deutschland GmbH C/O Mr. Alexander Schapovalov TUV SUD America, Incorporated 1775 Old Highway 8 North West NEW BRIGHTON MN 55112-1891

Re: K131404

Trade/Device Name: Flash AR Penta™, Flash AR Penta™ Quick Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 13, 2013 Received: May 23, 2013

Dear Mr. Schapovalov:

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.

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Page 2 - Mr. Schapovalov

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

| | Digitally signed by Mary S. Runner -S<br>ON: C=US, O=U.S. Government,<br>OU=HHS, OU=FDA, ou=People,<br>cn=Mary S. Runner -5,<br>0.9.2342.19200300.100.1.1=13000879 |
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Susan Runner, DDSMA |
| | Date: 2013.05.30 10:37:12 -04'00' |

Anthony D. Watson, B.S., M.S., M.B.A.

Director

Division of Anesthesiology, General Hospital,

Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

#### Enclosure

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#### 1.5 Statement of Indications for Use

### Indications for Use

| 510(k) Number (if known): | K131404 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

Flash AR Penta™ Flash AR Penta™ Quick .

Indications For Use:

- . Impressions for the production of temporary restorations
- All types of preliminary impressions .
- Impressions of the opposing jaw .
- Impressions for orthodontic models .

| Prescription Use (Part 21 CFR 301 Subpart D) | <b>X</b> |
|----------------------------------------------|----------|
|----------------------------------------------|----------|

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)

Digitally signed by Mary S. Runner -S

DN: c=US; o=U.S. Government, ou=HHS,

ou=FDA, ou=People, cn=Mary S. Runner

0.9.2342.19200300.100.1.1=1300087950

Date: 2013.05.30 10:35:04 -04'00'

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | KB1404 |
|----------------|--------|
|----------------|--------|

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