POLY Q (GARANT L, PENTA M, PENTA H)

K032001 · 3M Espe AG Dental Products · ELW · Aug 11, 2003 · Dental

Device Facts

• Record ID: K032001
• Device Name: POLY Q (GARANT L, PENTA M, PENTA H)
• Applicant: 3M Espe AG Dental Products
• Product Code: ELW · Dental
• Decision Date: Aug 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Indications for Use

Poly Q Garant L: Wash material for dual phase impression techniques. Poly Q Penta M: Impression material for monophase technique. Poly Q Penta H: Tray material for dual phase impression techniques.

Device Story

Poly Q is a dental impression material available in three viscosities: light body (Garant L), medium body (Penta M), and heavy body (Penta H). The material consists of a base paste and catalyst. Penta M and Penta H are two-component materials dispensed via the 3M ESPE Pentamix device; Garant L is dispensed via the 3M ESPE Garant device. The material is used by dental professionals to reproduce the structure of a patient's teeth. The device functions by capturing the anatomical details of the oral cavity, which are then used by the clinician to create dental models for restorative or diagnostic purposes.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed to demonstrate safety. Effectiveness was established by comparing performance characteristics of the subject devices to the predicate devices.

Technological Characteristics

Impression material (21 CFR 872.3660). Two-component (base paste/catalyst) system. Viscosities: light, medium, and heavy body. Dispensing systems: Pentamix (for Penta M/H) and Garant (for Garant L).

Indications for Use

Indicated for dental impression procedures: Poly Q Garant L as wash material for dual phase techniques; Poly Q Penta M for monophase techniques; Poly Q Penta H as tray material for dual phase techniques.

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

• Impregum Garant L DuoSoft (K994190)
• Impregum Penta M Monosoft (K994192)
• Impregum Penta H DuoSoft (K994193)

Submission Summary (Full Text)

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

AUG 1 1 2003

# K032001

# 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, |
| | Manager U.S. Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| US Agent: | Don H. McKenzie |
| | Regulatory Manager |
| Phone: | 651-736-9286 |
| Fax: | 651-736-0990 |
| E-mail: | [e-mail] |
| Date: | June 17, 2003 |

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

### Name of Device

Proprietary Name:

Classification Name

Common Name:

Poly Q Garant™ L Poly Q Penta™ M Poly Q Penta™ H Impression material Dental impression material

#### Predicate Device:

| Poly Q GarantTM L: | ImpregumTM GarantTM L DuoSoft, K 994190 |
|--------------------|-----------------------------------------|
| Poly Q PentaTM M: | ImpregumTM PentaTM M Monosoft, K 994192 |
| Poly Q PentaTM H: | ImpregumTM PentaTM H DuoSoft, K 994193 |

#### Description for the Premarket Notification

Poly Q is classified as Impression material ( 21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.

Poly Q will be available in three different viscosities, called Poly Q Garant™ L (light body), Poly Q Penta™ M (medium body) and Poly Q Penta™ H (heavy body).

Poly Q Penta M and Poly Q Penta H are two component (base paste/catalyst) materials to automatically be mixed in dispensed in 3M ESPE's Pentamix™ device. Poly Q Garant L is a material designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™.

To provide evidence for safety biocompatibility testing was carried out. The results show that Poly Q is a safe device.

To prove the effectiveness of Poly Q, the performance characteristics of Poly Q Garant L, Poly Q Penta M and Poly Q Penta H were compared to the respective predicate devices.

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

In summary, the impression materials Poly Q Garant L, Penta M and Penta H, described in this 510(k) premarket notification submission, are, in our opinion, substantially equivalent to the respective predicate devices.

し、 : ・

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

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of a human face in profile, with three wavy lines extending from the face. The seal appears to be a logo or emblem for the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2003

Dr. Andreas Petermann Regulatory Manager, U.S Affairs 3M ESPE AG ESPE Platz 8229 Seefeld Bavaria, GERMANY

Re: K032001

Trade/Device Name: Poly Q Garant L, Poly Q Penta M, and Penta H Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: June 17, 2003 Received: June 27, 2003

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.

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

## 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 vour 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Susan Rooser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

人 032001 510(k) Number (if known): ___

Device Name: Poly Q (Poly Q Garant L, Poly Q Penta M, Poly Q Penta H)

Indications For Use:

Poly Q Garant L:

Wash material for dual phase impression techniques.

Poly Q Penta M:

Impression material for monophase technique.

Poly Q Penta H:

Tray material for dual phase impression techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Sbertz DDS for Dr K. Mulry

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

510(k) Number: K032001

(Optional Format 3-10-98)