(4 days)
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 putty (putty, putty fast set, putty soft) and Panasil binetics (putty fast, putty soft) are to be used as preliminary materials for:
-Two step putty/wash impression technique.
-One step putty/wash impression technique.
-Two step putty/wash impression technique using a foil (plastic putty spacer)
-One step putty impression technique for forming functional peripheries.
Panasil trav (fast. soft) 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.
Panasil monophase is to be used as a medium-bodied tray or syringeable impression material for:
-Taking impressions over fixed/removable restorations and implants
(transferring impression posts and bridge components).
-Functional impressions.
-Fabricating crown and bridgework or inlays.
-Fabricating full or partial dentures.
-Reline impressions.
-Use in the simultaneous mixing technique as well as the putty/wash and triple tray techniques.
-Transferring root posts when fabricating posts and cores indirectly.
Panasil contact (two in one, plus) 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® Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Panasil Impression Material family consists of five different viscosities (putty, heavy-bodied, medium-bodied, light-bodied, x-lightbodied), available in an assortment of delivery systems: traditional 1:1 50 ml automix cartridge, 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.
The provided document describes Panasil® Impression Materials, a dental impression material, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies) is not directly applicable or available in the given text.
However, I can extract the relevant information from the document considering it's a traditional medical device submission (dental impression material) and present it in a modified format that aligns with the spirit of your request, focusing on how its "performance" was assessed against established criteria.
Here's an interpretation based on the provided text, adapted for a non-AI/ML device:
Acceptance Criteria and Device Performance for Panasil® Impression Materials
The primary "acceptance criteria" for this traditional medical device product are based on demonstrating substantial equivalence to legally marketed predicate devices, as per the FDA 510(k) pathway. This equivalence is established through meeting applicable criteria from relevant guidance documents and international standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Derived from Standards/Guidance) | Referenced Standard/Guidance | Reported Device Performance/Conclusion |
|---|---|---|
| Technological Characteristics Equivalence | FDA Guidance for Industry and FDA Staff: Dental Impression Materials (FOD#2203, 8/17/1998) | Panasil® Impression Materials (Panasil putty, Panasil binetics, Panasil tray, Panasil monophase, Panasil contact) and the predicate devices are addition-curing, elastomeric materials designed and manufactured for use as dental impression materials, demonstrating substantial equivalence in technology. |
| Material Properties (e.g., tear strength, dimensional accuracy, resistance to permanent deformation, hydrophilic properties) | ISO 4823 (Dentistry – Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007 | The device has hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. Performance testing demonstrated suitability for use as dental impression materials, performing in a manner substantially equivalent to predicate devices. |
| Intended Use & Indications for Use Equivalence | Comparison with predicate devices (K954281, K021413, K021410, K050604) | The intended use for reproducing patient's teeth/gums for study models and prosthetic devices, and the specific indications for each Panasil product variation, are consistent with the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative sample size for performance testing. It generally refers to "device performance testing." For material characteristics of this type, testing would typically involve a statistically relevant number of samples of the material itself, rather than a "test set" of patient data.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given that Kettenbach GmbH & Co. KG is a German company, a significant portion of the material testing could have been conducted in Germany or by third-party labs. As this is a premarket notification for a material, the "data" would primarily be laboratory-based material characterization, not patient-derived data in the way an AI/ML diagnostic device uses it.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This concept is not applicable to this type of device. The "ground truth" for dental impression materials is established by objective physical and chemical measurements against recognized standards (like ISO 4823) and comparison to the properties of predicate devices. There wouldn't be "experts" establishing a clinical ground truth for a test set in the same way as for an image-based diagnostic AI.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication in the context of expert review for diagnostic outcomes is not relevant here. Device performance is determined by objective laboratory measurements and comparison to established specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a traditional dental impression material, not an AI-powered device, so no MRMC studies or human reader improvement with AI assistance were conducted or are relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a material, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for Panasil® Impression Materials is established by:
- Objective Material Property Measurements: Adherence to physical and chemical parameters defined in international standards like ISO 4823 (e.g., tear strength, dimensional stability, resistance to permanent deformation).
- Predicate Device Comparison: Direct comparison and demonstration of similar or identical properties and performance characteristics to previously cleared dental impression materials.
8. The Sample Size for the Training Set
- Not applicable. This is a traditional medical device (material), not an AI/ML algorithm that requires a "training set." The development of such materials involves chemical formulation and iterative testing, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
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Traditional Premarket Notitication [510(K)] Panasil® Impression Materials
ບບການປະເທດລ
510(K) Summary
SEP 0 8 2008
| SEP 08 2008 | |
|---|---|
| A. Submitter Information | |
| Submitter's Name: | Kettenbach GmbH & Co. KG |
| Address: | Im Heerfeld 7 |
| D-35713 | |
| Eschenburg, Germany | |
| Phone Number: | (+49) 2774-705-58 |
| Fax Number: | (+49) 2774-705-33 |
| Contact Person: | Michaela Zinke |
| Date of Preparation: | July 10, 2008 |
| B. Device Name | |
| Trade Name: | Panasil® Impression Materials, to include: |
| • Panasil® putty (putty, putty fast set, putty soft) | |
| • Panasil® binetics (putty fast, putty soft) | |
| • Panasil® tray (fast, soft) | |
| • Panasil® monophase | |
| • Panasil® contact (two in one, plus) | |
| Common/Usual Name: | Impression Material |
| Classification Name: | Material, Impression (21 CFR 872.3660, Product Code: ELW) |
| C. Predicate Devices | |
| Trade Name: | Panasil® Impression Materials (K954281) |
| Trade Name: | Aquasil Ultra Rigid Smart Wetting® Impression Materials (K021413) |
| Trade Name: | Aquasil Ultra XLV Smart Wetting® Impression |
Kerr VPS Impression Material (K050604)
Material (K021410)
Trade Name:
. .
{1}------------------------------------------------
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 Material family consists of five different viscosities (putty, heavy-bodied, medium-bodied, light-bodied, x-lightbodied), available in an assortment of delivery systems: traditional 1:1 50 ml automix cartridge, 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.
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 putty (putty, putty fast set, putty soft) and Panasil binetics (putty fast, putty soft) are to be used as preliminary materials for:
-Two step putty/wash impression technique.
-One step putty/wash impression technique.
- -Two step putty/wash impression technique using a foil (plastic putty spacer)
- -One step putty impression technique for forming functional peripheries.
Panasil trav (fast. soft) 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.
{2}------------------------------------------------
Panasil monophase is to be used as a medium-bodied tray or syringeable impression material for:
- -Taking impressions over fixed/removable restorations and implants
- (transferring impression posts and bridge components).
- -Functional impressions.
- -Fabricating crown and bridgework or inlays.
- -Fabricating full or partial dentures.
- -Reline impressions.
- -Use in the simultaneous mixing technique as well as the putty/wash and triple tray techniques.
- -Transferring root posts when fabricating posts and cores indirectly.
Panasil contact (two in one, plus) 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.
F. Technological Characteristics Summary
The technological characteristics of Panasil® Impression Materials are substantially equivalent to the predicate device technological characteristics. Panasil Impression Materials (Panasil putty, Panasil binetics, Panasil tray, Panasil monophase, Panasil contact) and the predicate devices are addition-curing, elastomeric materials designed and manufactured for use as dental impression materials.
{3}------------------------------------------------
G. Performance Data
No performance standards have been established for this type of device. Panasil® Impression Materials 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 device performance testing demonstrated that Panasil Impression Materials (Panasil putty, Panasil binetics, Panasil tray, Panasil monophase, Panasil contact) are suitable for use as dental impression materials. Panasil Impression Materials (Panasil putty, Panasil binetics, Panasil tray, Panasil monophase, Panasil contact) have been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 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-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
SEP 0 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kettenbach GmbH & Company KG C/O Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Incorporated 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891
Re: K082560
Trade/Device Name: Panasil® Putty (Putty, Putty Fast Set, Putty Soft), Panasil® Binetics (Putty Fast, Putty Soft), Panasil® Tray (Fast, Soft), Panasil® Monophase, Panasil® Contact (Two in One, Plus) Regulation Number: 872.3660 Regulation Name: Partially Fabricated Denture Kit Regulatory Class: II Product Code: ELW Dated: September 2, 2008 Received: September 4, 2008
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 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.
{5}------------------------------------------------
Page 2 - Mr. Preiss
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 CI'R 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.
Thhammelb. Lerdiner frell
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, Gencral Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
510(k) Number (if known): _ KO22560
Device Name: Panasil® putty (putty, putty fast set, putty soft),
Indications for Use:
Panasil putty (putty, putty fast set, putty soft) is to be used as a preliminary material for:
- -Two step putty/wash impression technique.
- -One step putty/wash impression technique.
- -Two step putty/wash impression technique using a foil (plastic putty spacer)
- -One step putty impression technique for forming functional peripheries.
| 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | 1082560 |
|---|---|
| ---------------- | --------- |
Page 1 of 5
{7}------------------------------------------------
510(k) Number (if known): $0825 60
Device Name: Panasil® binetics (putty fast, putty soft)
Indications for Use:
Panasil binetics (putty fast, putty soft) is to be used as a preliminary material for:
-Two step putty/wash impression technique.
-One step putty/wash impression technique.
-Two step putty/wash impression technique using a foil (plastic putty spacer)
- Two step putty/waon improberhnique for forming functional peripheries.
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)
Sina Ruom
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 2 of 5
510(k) Number:
Page 17 of 510
{8}------------------------------------------------
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Panasil® tray (fast, soft)
Indications for Use:
Panasil tray (fast, soft) 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 × (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) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 3 of 5
510(k) Number:
Kattanhach GmhH & C.n KG
Page 18 of 510
{9}------------------------------------------------
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Panasil® monophase
Indications for Use:
Panasil monophase is to be used as a medium-bodied tray or syringeable impression material for:
-Taking impressions over fixed/removable restorations and implants
(transferring impression posts and bridge components).
-Functional impressions.
- -Fabricating crown and bridgework or inlays.
-Fabricating full or partial dentures.
-Reline impressions.
-Use in the simultaneous mixing technique as well as the putty/wash and triple tray techniques.
-Transferring root posts when fabricating posts and cores indirectly.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runar
Division Sign-Off) )ivision of Anesthesiology, General Hospital nfection Control, Dental Devices
Page 4 of 5
10(k) Number: K082560
{10}------------------------------------------------
510(k) Number (if known): _KOKAS (eC)
Device Name: Panasil® contact (two in one, plus)
Indications for Use:
Panasil contact (two in one, plus) 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 (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)
| Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| nfection Control, Dental Devices | |
| 510(k) Number: | K082560 |
Page 5of 5
§ 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).