(25 days)
Not Found
No
The device description and intended use describe a traditional dental impression material, and there is no mention of AI or ML in the provided text.
No
The device is used to reproduce the structure of a patient's teeth and gums to provide models for study and production of restorative prosthetic devices, which is a diagnostic/restorative purpose, not a therapeutic one.
No
The device is an impression material used to reproduce the structure of teeth and gums for creating models and prosthetic devices, not to diagnose a condition or disease.
No
The device description clearly states it is an "addition-curing, elastomeric material" and is available in "automix cartridge and 5:1 362 ml foil bags," indicating it is 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 Panasil® Impression Materials are used to reproduce the structure of a patient's teeth and gums to create models for study and production of restorative prosthetic devices. This is a physical process of creating a mold, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the material properties and delivery systems, consistent with a dental impression material used for physical molding.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the material (dimensional accuracy, tear strength, etc.) and its suitability as a dental impression material, not on diagnostic accuracy metrics like sensitivity or specificity.
Therefore, the Panasil® Impression Materials are a medical device used for creating physical models, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
ELW
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.
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)
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.
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
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
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.
1
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.
2
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.
3
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.
4
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
5
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