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.

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ISO 4823 (Dentistry - Elastomeric impression materials):2000/Cor. 1:2004/Amd. 1:2007	Met applicable requirements. The Panasil® Impression Material subject devices were found suitable for use as dental impression materials.
Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998)	Met applicable requirements, demonstrating substantial equivalence to predicate devices.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that performance testing was conducted.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this device is based on compliance with established industrial standards (ISO 4823) and FDA guidance, rather than expert consensus on diagnostic images or similar data.

4. Adjudication Method for the Test Set

Not applicable. The testing appears to be quantitative measurements against technical specifications outlined in the referenced standards, not a qualitative assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/diagnostic imaging devices where human readers' performance with and without AI assistance is evaluated. The Panasil® Impression Materials are dental impression materials, which are physical devices.

6. Standalone Performance Study

Yes, a standalone study (algorithm only without human-in-the-loop performance) was effectively done. The performance data section states that the "Panasil® Impression Material subject devices... have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification... and ISO 4823." This indicates that the materials themselves were tested against a set of objective technical benchmarks.

7. Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory guidance. Specifically, the device's performance was evaluated against the technical requirements outlined in:

ISO 4823 (Dentistry - Elastomeric impression materials):2000/Cor. 1:2004/Amd. 1:2007
Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998)

8. Sample Size for the Training Set

Not applicable. This device is a dental impression material, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment process in that context.

Summary

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K083701

Kettenbach GmbH & Co. KG

Eschenburg, Germany

(+49) 2774-705-58

(+49) 2774-705-33

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

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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

{6}------------------------------------------------

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

Regulation Number and Section

§ 872.3660 Impression material.

(a)
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.(b)
Classification. Class II (Special Controls).