IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT

K092867 · Kettenbach GmbH & Co. KG · ELW · Oct 1, 2009 · Dental

Device Facts

• Record ID: K092867
• Device Name: IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT
• Applicant: Kettenbach GmbH & Co. KG
• Product Code: ELW · Dental
• Decision Date: Oct 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Identium® 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

Identium® Impression Materials are addition-curing, elastomeric dental materials used to capture precise anatomical structures of teeth and gums. Available in four viscosities (heavy, medium, medium soft, light) and two delivery systems (50 ml automix cartridges or 362 ml foil bags), they are dispensed by dental professionals using automatic mixing systems. The material is applied to an impression tray or injected directly into the patient's mouth. Once set, the resulting impression serves as a physical model for study or the fabrication of restorative prosthetic devices (crowns, bridges, dentures, implants). The material features high tear strength, dimensional accuracy, and resistance to deformation, aiding clinicians in achieving accurate dental restorations. No electronic or software components are involved.

Clinical Evidence

Bench testing only. Device performance evaluated per ISO 4823 (Dentistry – Elastomeric impression materials) and FDA Guidance for Industry and FDA Staff: Dental Impression Materials. Testing confirmed suitability for use as dental impression materials and substantial equivalence to predicate devices.

Technological Characteristics

Addition-curing, elastomeric dental impression material. Available in heavy, medium, medium soft, and light viscosities. Delivery via 1:1 (50 ml) or 5:1 (362 ml) automatic dispensing/mixing systems. Regular-set and fast-set versions available. Complies with ISO 4823 standards.

Indications for Use

Indicated for dental patients requiring impressions for crowns, bridges, inlays, onlays, veneer preparations, full or partial dentures, implants, fixation, reline, or functional impressions. Available in heavy, medium, medium soft, and light viscosities for one-step monophase or double-mix techniques. Prescription use only.

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, K083701)
• GC Fusion/SENN and Fusion Fast Set/SENN Impression Materials (K041398, K043471)

Submission Summary (Full Text)

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

K092867

#### Traditional Premarket Notification [510(k)] Identium® Impression Materials

### 510(K) Summary

### OCT - 1 2009

A. Submitter Information

Submitter's Name: Address:

Phone Number:

Contact Person:

Date of Preparation:

Fax Number:

Kettenbach GmbH & Co. KG lm Heerfeld 7 D-35713 Eschenburg, Germany ([phone] ([phone] Michaela Zinke July 24, 2009

- B. Device Name
Trade Name:

Common/Usual Name: Classification Name:

Identium® Impression Materials, to include:

- · Identium® Heavy
- · Identium® Medium
- · Identium® Medium soft
- · Identium® Light

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

C. Predicate Devices Trade Name:

Trade Names:

Panasil® Impression Materials (K082560, K083701) GC Fusion/SENN and Fusion Fast Set/SENN Impression Materials (K041398, K043471)

#### D. Device Description

Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Identium® Impression Materials family consists of three different viscosities (heavy-bodied, medium-bodied, light-bodied). They are available in two delivery systems, for use in most automatic dispensing and

Kettenbach GmbH & Co. KG

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

#### Traditional Premarket Notification [510(k)]

Identium® Impression Materials

mixing systems: standard 1:1 (50 ml automix cartridges) and 5:1 (362 ml foil bags). The Identium® Impression Materials are available in regular-set and fastset versions.

- E. Intended Use
The Identium® 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.
- F. Indications for Use

Identium Heavy is to be used as a heavy-bodied impression material in one-step technique (double mix) for:

- Impressions for crowns/bridges, inlays/onlays and veneer preparations .
- Functional impressions .
- Impressions for full or partial dentures .
- Implant impressions .

Identium Medium is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:

- Impressions for crowns/bridges, inlays/onlays and veneer preparations .
- Implant impressions .
- Fixation impressions .
- Functional impressions .

Identium Medium soft is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:

- · Impressions for crowns/bridges, inlays/onlays and veneer preparations
- Functional impressions ◀
- Reline impressions t

Kettenbach GmbH & Co. KG

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

### Traditional Premarket Notification [510(k)]

Identium® Impression Materials

Identium Light is to be used as a light-bodied, syringeable impression material in one-step technique (double mix) for:

- Impressions for crowns/ bridges, inlays/ onlays and veneer preparations .
- Reline impressions .
- Impressions for full or partial dentures .

#### G. Technological Characteristics Summary

The technological characteristics of Identium® Impression Materials are substantially equivalent to the predicate device technological characteristics. Identium® Impression Materials and the predicate devices are addition-curing, elastomeric materials, designed and manufactured for use as dental impression materials.

#### H. Performance Data

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

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and features an eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

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

# OCT -1 2009

TÜV SÜD America, Incorporated C/O Mr. Stefan Preiss Responsible Third Party Official Kettenbach GmbH & Company KG 1775 Old High Way 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

Re: K092867

Trade/Device Name: Identium® Light, Identium® Medium Soft, Identium® Medium, Identium® Heavy Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: September 16, 2009 Received: September 18, 2009

Dear Mr. Preiss:

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 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- Mr. Preiss

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

h for

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

Enclosure

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

Identium® Impression Materials

## Indications for Use

510(k) Number (if known):

Device Name: Identium® Light

Indications for Use:

Identium Light is to be used as a light-bodied, syringeable impression material in one-step technique (double mix) for:

- Impressions for crowns/bridges, inlays/onlays and veneer preparations ◆
- Reline impressions .
- Impressions for full or partial dentures .

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(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)

He M. Uley for HSR

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

510(k) Number

Kettenbach GmbH & Co. KG

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

### Traditional Premarket Notification [510(k)]

Identium® Impression Materials

# Indications for Use

510(k) Number (if known):

Device Name: Identium® Medium soft

Indications for Use:

Identium Medium soft is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:

- Impressions for crowns/bridges, inlays/onlays and veneer .
- preparations
- Functional impressions
- Reline impressions

Prescription Use X (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)

Ken Mulsby for NCS Page 3 of 4

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

Kettenbach GmbH & Co. KG

510 (k) Number

{7}------------------------------------------------

## Indications for Use

510(k) Number (if known):

K092867

Device Name: Identium® Medium

Indications for Use:

Identium Medium is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:

- Impressions for crowns/bridges, inlays/onlays and veneer � preparations
- Implant impressions
- Fixation impressions
- Functional impressions

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)

Kari Ruby for ASP
Page 2 of 4

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

Kettenbach GmbH & Co. KG

510(k) Numbe

{8}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: Identium® Heavy

Indications for Use:

Identium Heavy is to be used as a heavy-bodied impression material in onestep technique (double mix) for:

- Impressions for crowns/bridges, inlays/onlays and veneer preparations .
- Functional impressions .
- Impressions for full or partial dentures .
- Implant impressions �

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)

Kie Mulay for MSR Page 1 of 4

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

Kettenbach GmbH & Co. KG

10/k) N