(74 days)
CutterSil Activator Universal Plus paste and liquid are used as a catalyst to induce polymerization of the CutterSil base paste which is used for all inlay, crown and bridge, partial and edentulous impressions.
Hardener Universal Plus (Liquid and Paste) (identical with Activator Universal Plus, Liquid and Paste) is the catalyst of the two component condensation curing silicone dental impression material Cuttersil (hardener and base paste and hardener are mixed before use according to the instruction of use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hardener Universal Plus:
Device: Hardener Universal Plus (Liquid and Paste)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties: | |
| Fulfils requirements of EN ISO 4823 | The new D 890/3 hardener shows quite similar physical and handling properties in comparison to the old hardener. The new product also fulfils the requirements of EN ISO 4823. (Section 1) The physical data for the new D 890/3 hardener are in accordance with the functional specification for D 890/3 and the requirements of EN ISO 4823. (Section 4) The physical properties meet the requirements of the functional specification and EN ISO 4823. (Section 6) |
| Odor: | |
| Less intensive than old hardener | The odour of the new hardener is less intensive compared with the old hardener. (Section 1) |
| Biocompatibility: | |
| Verified in accordance with EN ISO 10993-1 | The biocompatibility of the new D 890/3 Hardener Universal Plus prototype was verified in combination with base paste in accordance with the international standard The biocompatibility of D 890/3 Hardener Universal Plus in combination with base paste was documented in a Biological Evaluation Report. (Section 3) |
| Benefit overweighs possible risks | The benefit overweights the possible risks with the use of the new hardener. (Section 3 and 6) |
| Effectiveness (detailed dental impressions): | |
| Effective for taking of detailed dental impressions | Based on the test data the new hardener it can be concluded is effective for taking of detailed dental impressions. (Section 4) |
| Clinical Performance & Safety: | |
| Exhibit claimed technical performance | It is concluded that the product can be expected to exhibit the claimed technical performance. (Section 5 and 6) |
| Potential undesirable clinical effects and risks well controlled and acceptable | Potential undesirable clinical effects and risks seem well controlled and acceptable when weighted against their benefits in dentistry. (Section 5 and 6) |
| Risk Analysis (EN ISO 14971): | |
| Acceptable risk when applied according to instructions | The risk analysis according to EN ISO 14971 was carried out for the new D 890/3 hardener and showed that the application of D 890/3 according to the manufacturer's instruction for use shows an acceptable risk. (Section 6) |
| Overall Regulatory Compliance: | |
| Meets all relevant requirements for condensation curing silicone impression materials and Medical Device Directive 93/43/EWG | The new D 890/3 hardener meets all relevant requirements for condensation as an early wa rite new b osons hardoner moote and the Medical Device Directive 93/43/EWG SMCone Inforestion matomation. (Section 6, with some illegible text in the original) |
| Effective and safe when used according to manufacturer's instructions | Based on the actual facts D 890/3 and Trailonal Editipean Thousan "Chica" (c. be effective and safe when using it in accordance with the manufacturer's information for use. (Section 6, with some illegible text in the original) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set regarding the physical properties or biocompatibility. It states that "test data" was used (Section 4) and that the biocompatibility was "verified" and "documented in a Biological Evaluation Report" (Section 3).
Data Provenance: The manufacturer, Heraeus Kulzer GmbH, is based in Dormagen, Germany. The evaluations mention compliance with European medical device legislation (Medical Device Directive 93/42/EWG) and international standards (EN ISO), suggesting the data originates from studies conducted or accepted within the European context. The document itself is a 510(k) Summary, which is a submission to the US FDA, so the data is being presented for US regulatory review. The type of data appears to be retrospective in the sense that the studies (biocompatibility, physical properties) were completed prior to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Toxicological Expert Opinions: "In addition toxicological expert opinions are carried out to assess possible risks..." (Section 3). The number of experts is not specified, nor are their specific qualifications (e.g., years of experience, specific board certifications).
- Clinical Evaluation Expert: "...expert stated for hardener D B90/3 that the benefits overweight the possible risks if the product is applied according to the instruction for use." (Section 5). The number of experts is referred to in the singular ("expert"), and no specific qualifications are provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for establishing ground truth from multiple expert opinions (e.g., 2+1, 3+1). It refers to "expert opinions" (plural) for toxicology and a singular "expert" for the clinical evaluation conclusion. This suggests a potential lack of formal adjudication for consensus if multiple individual opinions were initially present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The device described is a dental impression material hardener. It is a material, not an AI-powered diagnostic or assistive device that would involve human "readers" or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a material, not an algorithm.
7. The Type of Ground Truth Used
- Physical Properties: The ground truth for physical properties was established by testing against established international standards (EN ISO 4823) and functional specifications. These standards define measurable parameters and acceptable ranges.
- Biocompatibility: The ground truth for biocompatibility was established by testing according to EN ISO 10993-1, which involves a series of standardized tests to assess biological responses.
- Toxicological Evaluation: Ground truth was established through toxicological expert opinions and risk assessments.
- Clinical Evaluation: Ground truth was established by an expert's conclusion based on evaluated data, clinical evaluation, and technical results, weighing benefits against risks. This leans towards expert consensus/opinion based on available evidence.
8. The Sample Size for the Training Set
This information is not provided and is likely not applicable in the typical sense of machine learning "training sets" as this is a material science and biocompatibility assessment, not an AI/algorithm development. The "training" in this context would refer to the development and formulation of the hardener itself, which is not quantified by a sample size in this document.
9. How the Ground Truth for the Training Set Was Established
As with point 8, this is not explicitly stated or readily applicable in the context of this device type. The "ground truth" for the development (or "training") of a material like this would involve iterative testing and refinement based on desired physical properties, handling characteristics, and biocompatibility, continuously measured against industry standards and internal specifications.
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caeus Kurzer Grooti Ane Hearstraße 41538 Dormage
Heraeus Kalzar GmbH Denlistry Division Alle Heerstraße D-41538 Domagen
Research & Development Impression Contact Name: Dr. M. Grunweld Phone + 49 (0) 2133 51 45 83 Fax + 49 (0) 2133 51 34 74 Marlin Grunwald(")heraeus.com www.heraeus-kulzer.com
Your reference Our reference: gwwt1790 Your correspondence of
07 January 2008
510 (k) Summary of Safety and Effectiveness of Hardener Universal Plus (Liquid and Paste) (Project No .: D890/3)
1. Description and intended Use of the Medical Device:
Hardener Universal Plus (Liquid and Paste) (identical with Activator Universal Plus, Liquid and Paste) is the catalyst of the two component condensation curing silicone dental impression material Cuttersil (hardener and base paste and hardener are mixed before use according to the instruction of use.
There is no change in the intended use of the Cuttersil Impression Material because Hardener Universal Plus is a substitute for CutterSil Universal Hardener and the base material remains unchanged. The new D 890/3 hardener has some advantages by comparison with the Cuttersil Hardener Universal:
The odour of the new hardener is less intensive compared with the old hardener. ・
- The new D 890/3 hardener shows quite similar physical and handling properties in comparison to the old hardener. The new product also fulfils the requirements of EN 150 4823.
2. Indication List:
There is no change in the indications when using the new D 890/3 Hardener Universal Plus instead of the "old" Cuttersil Hardener Universal.
Sitz der Gesellschaft Hanau · Registergericht Amtsgericht Hanau HRB 91228 · USt-IdNr. DE 812 593 096 Geschäftsführer: Dr. Martin Haase, Dr. Andre Kobelt Vorsitzender des Aufsichtsrales: Jan Rinnerl
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Seite 2
3. Toxicological Evaluation:
In accordance with the Medical Device Directive 93/42/EWG and national European medical device legislation a medical device is required to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with EN ISO 10993-1.
The biocompatibility of the new D 890/3 Hardener Lniversal Plus prototype was verified in combination with base paste in accordance with the international standard The biocompatibility of D 890/3 Hardener Universal Plus in combination with base paste was documented in a Biological Evaluation Report. The benefit overweights the possible risks with the use of the new hardener.
In addition toxicological expert opinions are carried out to assess possible risks by using D 890/3 as hardener in condensation curing dental silicone impression materials and to evaluate recommendations for appropriate warnings. These risk assessments and recommendations have been taken into account in the instruction for use and in the clinical evaluation
4. Physical Properties and Compliance with International Standard EN ISO 4823:
There are only minor changes of physical properties by using the new D 890/3 activator Hardener Universal Plus instead of the "old" Cuttersil Hardener Universal which do not affect the effectiveness of the medical device adversely. The physical data for the new D 890/3 hardener are in accordance with the functional specification for D 890/3 and the requirements of EN ISO 4823.
Based on the test data the new hardener it can be concluded is effective for taking of detailed dental impressions.
5. Clinical Evaluation:
D 890/3 Hardener Universal Plus is a hardener for condensation curing dental impression material which is in general classified as a class I medical device under the Medical Device Directive 93/42/EEC.
Considering the evaluated data, clinical evaluation and technical results for D 890/3 hardener it is concluded that the product can be expected to exhibit the claimed technica! performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighted against their berefits in dentistry. Therefore the expert stated for hardener D B90/3 that the benefits overweight the possible risks if the product is applied according to the instruction for use.
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Seite 3
6. Summarized Evaluation:
D 890/3 Cuttersil Hardener Universal Plus is a substitute for Cuttersil Hardener Universal. The type of setting reaction is well known and does not change.
The physical properties meet the requirements of the functional specification and EN ISO r ric propertiou firsperition of the new hardener was tested according to the requirements 4623. The Uloompaninery in this toxicological expert opinions have been carried out. The or EN 100 Tobbo and additions wed the benefit overweights the possible risks with the use of the new hardener.
Based on the results of the clinical evaluation it is concluded that the product can be Dasco on the voules of amed performance and that potential undesirable clinical effects expected to exhibit the claimou porceptable when weighed against their benefit in dentistry.
The risk analysis according to EN ISO 14971 was carried out for the new D 890/3 hardener and showed that the application of D $90/3 according to the manufacturer's instruction for use shows an acceptable risk.
The new D 890/3 hardener meets all relevant requirements for condensation as an early wa rite new b osons hardoner moote and the Medical Device Directive 93/43/EWG SMCone Inforestion matomation. Based on the actual facts D 890/3 and Trailonal Editipean Thousan "Chica" (c. be effective and safe when using it in accordance with the manufacturer's information for use.
Dr. Martin Grunwald Date: 24.01.96 Signature:
Annegrete Wegner Date: 20.01.96 Signature:
Release:
Dr Barbara Bräu
Date:
Sichature
AS AS. T.M.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2008
Heraeus Kulzer GmbH C/O Ms. Cheryl Zimmerman Director, Quality Assurance & Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614
Re: K080338
Trade/Device Name: CutterSil Hardener Universal Plus Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: FLW Dated: February 4, 2008 Received: February 11, 2008
Dear Ms. Zimmerman:
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.
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Page 2 - Ms. Zimmerman
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 (OS) 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chih Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of_1_ 086338 510(k) Number (if Known):
Device Name: CutterSil Hardener Universal Plus
Indications For Use:
CutterSil Activator Universal Plus paste and liquid are used as a catalyst to induce polymerization of the CutterSil base paste which is used for all inlay, crown and bridge, partial and edentulous impressions.
(PLEASE DO NOT WRITE BELOW THIS LINE:-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
Prescription Use
OR
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: карова
Civer-The-Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).