(7 days)
Not Found
No
The device description and intended use clearly define the product as a physical impression material, not a software or system that would utilize AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is an impression material used to create models of teeth and gums for diagnostic and restorative purposes, not to directly treat a medical condition.
No
Explanation: The device is an impression material used to reproduce the structure of a patient's teeth and gums for the production of restorative prosthetic devices. It does not analyze patient data or provide a diagnosis of a medical condition.
No
The device is described as an "addition-curing, elastomeric material" and is used to physically reproduce the structure of teeth and gums. This indicates a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Identium® Impression Materials are used to "reproduce the structure of a patient's teeth and gums" and "provide models for study and for production of restorative prosthetic devices." This describes a physical process of creating a mold for dental work.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. The Identium® Impression Materials do not perform any such diagnostic testing on biological samples.
- Device Description: The device description focuses on the physical properties of the material (elastomeric, flow, hydrophilic, strength, accuracy) and its delivery systems, not on any analytical or diagnostic function.
- Performance Studies: The performance studies mentioned evaluate the material's suitability as a dental impression material based on physical properties and standards for such materials, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
The Identium® Impression Materials are a dental device used for creating physical impressions, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for 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.
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
- Impressions for full or partial dentures
- Implant impressions
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
- 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
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
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
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 요preparations
- Functional impressions 디
- Impressions for full or partial dentures I
-
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 해 preparations
- 미 Functional impressions
- Fixation impressions t
- Implant impressions 出
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
Product codes (comma separated list FDA assigned to the subject device)
ELW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth and gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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)
1
-
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).
3
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.
4
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.
5
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