(7 days)
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.
Identium® Heavy (regular 1:1, fast 1:1) 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 (regular 1:1, fast 1:1) 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
- Fixation impressions
- Implant impressions
Identium® Scan Heavy (regular 1:5) 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® Scan Medium (regular 1:5) 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
- Fixation impressions
- Implant impressions
Identium® Scan Light (regular 1:1) is to be used as a syringeable light-bodied 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
Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high shear strength, dimensional accuracy and resistance to permanent deformation. The Identium® Impression Materials include three different viscosities (heavy-bodied, medium-bodied, light-bodied), available in an assortment of delivery systems: Traditional 1:1 50 ml automix cartridge version and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems (heavy-bodied and medium-bodied versions only). Most of the Identium® Impression Materials are available in a regular-set and a fast-set version.
This looks like a 510(k) premarket notification for dental impression materials, not an AI/ML device. Therefore, the typical "acceptance criteria and study that proves the device meets the acceptance criteria" structure, especially concerning AI/ML performance metrics, ground truth, expert adjudication, MRMC studies, and training sets, does not apply here.
Instead, this document describes a traditional medical device submission where substantial equivalence is demonstrated through:
- Comparison to predicate devices: Showing the new device has similar intended use and technological characteristics to legally marketed devices.
- Performance testing to established standards: Demonstrating compliance with relevant industry and regulatory standards for non-AI devices.
Here's how I can address the request based on the provided document, adapting the categories where necessary:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Standard | Description | Reported Device Performance |
|---|---|---|
| Premarket Notification Guidance | "Guidance for Industry and FDA Staff: Dental Impression Materials - Premarket Notification (FOD#2203, 8/17/1998)" | "The results of performance testing demonstrated that Identium® Impression Material subject devices... are suitable for use as dental impression materials." |
| ISO 4823:2000/Cor 1:2004/Amd 1:2007 | "Dentistry - Elastomeric impression materials." This standard specifies requirements and test methods for elastomeric impression materials for dental purposes. | "Identium® Impression Material subject devices... evaluated in accordance with the applicable criteria established in... ISO 4823... The results of performance testing demonstrated that Identium® Impression Material subject devices... are suitable for use as dental impression materials." |
| Substantial Equivalence | The device should be as safe, as effective, and perform as well as or better than predicate devices. | "Identium® Impression Material subject devices... have been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices." "Based upon the similar intended use, the performance data according to ISO 4823, the evaluation/justification of the biocompatibility and the risk analysis acc. ISO 14971 the subject devices... are substantially equivalent to the predicate devices and can be considered to be as safe, as effective and performs as well as or better than the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This information is typically not included in a 510(k) summary for material performance testing. Standard ISO tests for dental materials use specific sample numbers as defined within the standard itself (e.g., a certain number of specimens for tensile strength, dimensional accuracy, etc.), but these details are not provided in this high-level summary. The data provenance would be laboratory testing conducted by or for the manufacturer (Kettenbach GmbH & Co. KG, Germany).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. "Ground truth" in the context of AI/ML refers to verified labels for image data, clinical diagnoses, etc. For material performance, the "truth" is determined by objective physical and chemical testing methods outlined in standards like ISO 4823, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. Material performance tests are quantitative measurements (e.g., measuring dimensional change, tear strength) and do not involve human adjudication in the sense of reviewing cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. This document is for a dental impression material, which is a physical product, not a diagnostic imaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not applicable or performed. This device is a material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective laboratory measurements dictated by the test methods in ISO 4823. This includes quantifiable properties like dimensional stability, tear strength, elastic recovery, etc., measured against the defined acceptance limits within the standard. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
Not applicable. This device is a material, not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Special Premarket Notification [510(k)] Identium® Impression Materials
510(K) Summary
A. Submitter Information . Submitter's Name: Address:
Phone Number:
Contact Person:
Date of Preparation:
Fax Number:
Kettenbach GmbH & Co. KG Im Heerfeld 7 D-35713 Eschenburg, Germany (+49) 2774-705-58 (+49) 2774-705-87 Simone Matuschka August 156, 2011
B. Device Name
Trade Name:
Identium® Impression Materials, to include:
- · Identium® Heavy (regular - and fast-set in 1:1 cartridge system)
- · Identium® Medium (regular - and fast- set in 1:1 cartridge system)
- · Identium® Scan Heavy (regular-set in 1:5 foil bag)
- · Identium® Scan Medium (regular-set in 1:5 foil bag)
- Identium® Scan Light (regular-set in 1:1 cartridge)
Common/Usual Name:
Impression Material
Classification Name:
Material, Impression (21 CFR 872.3660, Product Code: ELW)
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-
C. Predicate Devices
Trade Name: -
Identium® Impression Materials (K092867) including: .
Identium® Heavy (regular and fast set in 1:5 foil bag)
Identium® Medium (regular and fast set in 1:5 foil bag system),
Identium® Light (regular and fast set in 1:5 foil bag system)
D. Device Description
Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high shear strength, dimensional accuracy and resistance to
-permanent deformation. The Identium® Impression Materials include three different viscosities (heavy-bodied, medium-bodied, light-bodied), available in an assortment of delivery systems:
Traditional 1:1 50 ml automix cartridge version and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems (heavy-bodied and medium-bodied versions only). Most of the Identium® Impression Materials are available in a regular-set and a fast-set version.
-
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.
{2}------------------------------------------------
Heavy - bodied Identium® Impression Materials (fast- and regular set) are to be used for:
- Impressions for crowns/bridges, inlays/onlays and veneer preparations
- Functional impressions 체
- Impressions for full or partial dentures .
- Implant impressions 8
Medium - bodied Identium® Impression Materials (fast- and regular set) are to be used for:
- Impressions for crowns/bridges, inlays/onlays and veneer preparations
- Functional impressions .
- Fixation impressions 트
- Implant impressions
Ligtht - bodied Identium® Impression Materials (fast- and regular set) are to -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------be used for:
- Impressions for crowns/bridges, inlays/onlays and veneer ● preparations
- Reline impressions
- Impressions for full or partial dentures
- F. Technological Characteristics Summary
The technological characteristics of the Identium® Impression Material subject devices Identium® Heavy (in 1:1 cartridge), Identium® Medium(in 1:1 cartridge) Identium® Scan Heavy, Identium® Scan Medium and Identium® Scan Light are substantially equivalent to the Identium®, Panasil® and Futar®Scan 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 (product code ELW).
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Special Premarket Notification [510(k)] Identium® Impression Materials
G. Performance Data
No performance standards have been established for this type of device. Identium® Impression Material subject devices (Identium® Heavy and Identium® Medium in 1:1 cartridges, Identium® Scan Heavy , Identium® Scan Medium and Identium® Scan Light) 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 Identium® Impression Material subject devices (Identium® Heavy and Identium® Medium in 1:1 cartridges, Identium® Scan Heavy , Identium® Scan Medium and Identium® Scan Light) are suitable for use as dental impression materials. Identium® Impression Material subject devices(Identium® Heavy and Identium® Medium in 1:1 cartridges, Identium® Scan Heavy , Identium® Scan Medium and Identium® Scan Light) have been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.
- H. Clinical Tests
Clinical testing has not been conducted on the subject devives.
I. Conclusion
Based upon the similar intended use, the performance data according to ISO 4823, the evaluation/justification of the biocompatibility and the risk analysis acc. ISO 14971 the subject devices (Identium® Heavy and Identium® Medium in 1:1 cartridges, Identium® Scan Heavy , Identium® Scan Medium and Identium® Scan Light) are substantially equivalent to the predicate devices and can be considered to be as safe, as effective and performs as well as or better than the predicate devices.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion on the left. The caduceus symbol is depicted with three wavy lines representing snakes intertwined around a staff.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 4 2011
Kettenbach GmbH & Co. KG C/O Mr. Norbert Stuiber TUV SUD America, Inc. 1775 Old Highway 8, NW New Brighton, MN 55112-1891
Re: K113279
Trade/Device Names: Identium® Impression Materials (Heavy, Medium, Scan Heavy, Scan Medium, and Scan Light)
Regulation Number: 21 CFR 872.3660
Regulation Name: Impression Material
Regulatory Class: II
Product Code: ELW
Dated: November 3, 2011
Received: November 7, 2011
Dear Mr. Stuiber:
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. Stuiber
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital; Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{6}------------------------------------------------
510(k) Number (if known): ( 1 ( 32 7 M
Device Name:
,
Identium® Heavy
Indications For Use:
Identium® Heavy (regular 1:1, fast 1:1) 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 a preparations
- Functional impressions
- Impressions for full or partial dentures
- Implant impressions
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)
Page 1 of 5
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113279
{7}------------------------------------------------
510(k) Number (if known):
Device Name:
Identium® Medium
Indications For Use:
Identium® Medium (regular 1:1, fast 1:1) 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 u
- preparations
- 미 Functional impressions
- Fixation impressions B
- Implant impressions
Prescription Use X
(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)
Suren Kumar
(Division Sign-Off)
Page 2 of 5
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K113270
{8}------------------------------------------------
11 113279 510(k) Number (if known):
Device Name:
Identium® Scan Heavy
Indications For Use:
Identium® Scan Heavy (regular 1:5) 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 요 preparations
- Functional impressions 디
- Impressions for full or partial dentures I
-
Implant impressions
Prescription Use _ X (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)
Page 3 of 5
(Division Sign-Off) production Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices information of Anesthesiology, General Devices
T
510(k) Number: k<113279
{9}------------------------------------------------
1113279 510(k) Number (if known):
Device Name:
Identium® Scan Medium
Indications For Use:
Identium® Scan Medium (regular 1:5) 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 해 preparations
- 미 Functional impressions
- Fixation impressions t
- Implant impressions 出
Prescription Use . X (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)
Page 4 of 5
(Division Sign-Üff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number
{10}------------------------------------------------
K 113279
510(k) Number (if known):
Device Name: Identium® Scan Light
Indications For Use:
Identium® Scan Light (regular 1:1) is to be used as a syringeable light-bodied impression material in one-step technique (double mix) for:
- Impressions for crowns/bridges, inlays/onlays and veneer 트 preparations
- Reline impressions
- Impressions for full or partial dentures
Prescription Use __ X (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) ﻟﻤﺪﻳﻨﺔ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 5 of 5
Wh
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC113279
§ 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).