PANASIL INITIAL CONTACT AND PANASIL TRAY

K083701 · Kettenbach GmbH & Co. KG · ELW · Jan 9, 2009 · Dental

Device Facts

• Record ID: K083701
• Device Name: PANASIL INITIAL CONTACT AND PANASIL TRAY
• Applicant: Kettenbach GmbH & Co. KG
• Product Code: ELW · Dental
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

The Panasil® Impression Materials are intended to: be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; provide models for study and for production of restorative prosthetic devices.

Device Story

Panasil® Impression Materials are addition-curing, elastomeric dental materials with hydrophilic properties, high tear strength, and dimensional accuracy. Available in four viscosities (heavy, medium, light, x-light) and various delivery systems (50 ml automix cartridges, 362 ml foil bags). Used by dental professionals in clinical settings to capture precise anatomical structures of teeth and gums. Material is placed on impression trays or injected directly into the patient's mouth to create physical models for study or fabrication of prosthetic devices. Benefits include high dimensional stability and resistance to deformation, facilitating accurate restorative outcomes.

Clinical Evidence

Bench testing only. Evaluated per ISO 4823 (Dentistry - Elastomeric impression materials) and FDA Guidance for Industry and FDA Staff: Dental Impression Materials. Results demonstrate performance characteristics (dimensional accuracy, tear strength, resistance to deformation) equivalent to predicate devices.

Technological Characteristics

Addition-curing, elastomeric dental impression material. Hydrophilic properties. Available in multiple viscosities (heavy, medium, light, x-light). Delivery via 1:1 50 ml automix cartridges or 5:1 362 ml foil bags for automatic dispensing systems. Complies with ISO 4823:2000/Cor. 1:2004/Amd. 1:2007.

Indications for Use

Indicated for dental patients requiring impressions for restorative prosthetic devices, full or partial dentures, reline impressions, or functional impressions. Used via syringeable or heavy-bodied techniques (one-step or two-step putty-wash). No specific age or gender contraindications stated.

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

• Panasil® Impression Materials (K082560)

Submission Summary (Full Text)

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K083701

Kettenbach GmbH & Co. KG

Eschenburg, Germany

([phone]

([phone]

December 10, 2008

Michaela Zinke

# Special Premarket Notification [510(k)]

Panasil® Impression Materials

## Confidential

## 510(K) Summary

lm Heerfeld 7

D-35713

JAN - 9 2009

A. Submitter Information Submitter's Name: Address:

> Phone Number: Fax Number: Contact Person: Date of Preparation:

B. Device Name Trade Name:

Panasil® Impression Materials, to include:

- Panasil® initial contact (regular, regular fast, light, light fast, x-light, x-light fast)
- · Panasil® tray (fast 1:1, soft fast 5:1, soft fast 1:1)

Common/Usual Name:

Classification Name:

Impression Material

Material, Impression (21 CFR 872.3660, Product Code: ELW)

- C. Predicate Devices Trade Name:
Panasil® Impression Materials (K082560)

#### D. Device Description

Panasil® Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Panasil Impression Materials include four different viscosities (heavy-bodied, medium-bodied, light-bodied, x-light-bodied), available in an assortment of delivery systems: traditional 1:1 50 ml automix cartridge and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems.

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#### E. Intended Use

The Panasil® Impression Materials are intended to:

- be placed on an impression tray (or injected directly into the mouth,
- depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
- provide models for study and for production of restorative prosthetic devices.

#### Indications for Use

Panasil® initial contact (regular, regular fast, light fast, x-light, x-light fast) is to be used as a syringeable impression material for:

- · Two-step putty-wash impression technique.
- · One-step putty-wash impression technique.
- · One-step impression technique using a foil (plastic putty spacer).
- · One-step impression technique (simultaneous technique) using dual viscosities.
- · Reline impressions.
- · Fabricating full or partial dentures.

Panasil® tray (fast 1:1, soft fast 5:1, soft fast 1:1) is to be used as a heavy-bodied material for:

- · One-step impression technique (simultaneous technique) using single or dual viscosities.
- · Two-step impression technique using dual viscosities.
- Functional impressions.
- Technological Characteristics Summary

The technological characteristics of the Panasil® Impression Material subject devices (Panasil® initial contact, Panasil® tray) are substantially equivalent to the Panasil Impression Material predicate devices' technological characteristics. The subject devices and the predicate devices are addition-curing, elastomeric materials, designed and manufactured for use as dental impression materials.

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#### G. Performance Data

No performance standards have been established for this type of device. Panasil® Impression Material subject devices (Panasil® initial contact, Panasil® tray) have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998) and ISO 4823 (Dentistry - Elastomeric impression materials):2000/Cor. 1:2004/Amd. 1:2007. The results of performance testing demonstrated that Panasil Impression Material subject devices (Panasil initial contact, Panasil tray) are suitable for use as dental impression materials. Panasil Impression Material subject devices (Panasil initial contact, Panasil tray) have been designed and manufactured to perform in a manner substantially equivalent to that of the Panasil Impression Material predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes extending from its body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the left side of the image. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kettenbach GmbH & Company KG C/o Ms. Kristi Kistner President Pacific Otter Works, Incorporated 975 Veronica Springs Road Santa Barbara, California 93105

JAN - 9 2009

Re: K083701

> Trade/Device Name: Panasil® Initial Contact (regular, regular fast, light, light fact, x-light, x-light fact) Impression Material, Panasil® Tray (fast 1:1, soft fast 5:1,

Soft fast 1:1) Impression

Regulation Number: 21 CFR 872.3660

Regulation Name: Impression Material

Regulatory Class: II

Product Code: ELW

Dated: December 10, 2008

Received: December 15, 2008

Dear Ms Kistner:

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 - Ms. Kistner

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 [phone]. 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 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 yours.

Sura Runge

Ginette Y. Michaud, MD Acting 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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Confidential

# Indications for Use

283701

510(K) Number (if known)

Device Name

Panasil® initial contact (regular, regular fast, light, light fast, x-light, x-light fast) Impression Material

## Indications for Use

Panasil initial contact (regular, regular fast, light, light fast, x-light, x-light fast) is to be used as a syringeable impression material for:

- · Two-step putty-wash impression technique.
- · One-step putty-wash impression technique.
- · One-step impression technique using a foil (plastic putty spacer).
- · One-step impression technique (simultaneous technique) using dual viscosities.
- · Reline impressions.
- · Fabricating full or partial dentures.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Page 1 of 2

Page 20 of 254

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

Concurrence of CDRH, Office of Device Evaluation (ODE) users Juni

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

510(k) Number: .

Kettenbach GmbH & Co. KG

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Confidential

# Indications for Use

(08370)

## 510(K) Number (if known)

. . .

## Panasil® tray (fast 1:1, soft fast 5:1, soft fast 1:1) Impression Material

## Indications for Use

Device Name

Panasil tray (fast 1:1, soft fast 5:1, soft fast 1:1) is to be used as a heavy-bodied material for:

- One-step impression technique (simultaneous technique) using single or dual viscosities.
- · Two-step impression technique using dual viscosities.
- · Functional impressions.

Prescription Use X Prescription Ose 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)

Suorl Lusse

Page 2 of 2

Page 21 of 254

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

510(k) Number: K083270

Kettenbach GmbH & Co. KG