(1 days)
PRESIDENT The Original Xtra light body / light body / regular body:
- Correction material for the corrective impression technique
- Injection material for the double mix technique
- Injection material for the dual arch technique»
- Lining impression material
PRESIDENT The Original heavy body:
- Impression material for pick-up impression in the double mix technique
- Tray material for corrective impression technique
- Tray material for dual arch technique
PRESIDENT The Original System 360:
- Impression material for pick-up impression in the double mix technique
- Tray material for corrective impression technique
- Tray material for dual arch technique
PRESIDENT The Original putty / putty soft / putty super soft / fast putty soft
- Impression material for pick-up impression in the double mix technique
- Tray material for corrective impression technique
The subject device family is PRESIDENT The Original which consists of addition type silicone based dental impression materials. PRESIDENT The Original is the relaunch and improved version of the predecessor device PRESIDENT (K811767), which is on the market since 1981.
PRESIDENT The Original is a two base system consisting of base and catalyst that are mixed together before use. The product portfolio of the subject device PRESIDENT The Original can be broadly subdivided into tray materials and wash materials, according to their physical and chemical properties.
The tray materials have a higher tear strength and elasticity than the wash materials. PRESIDENT The Original System 360 devices are surface activated and thixotropic with fast pressure build up so that the wash material is driven into the clinically critical areas. PRESIDENT The Original putties are offered in three different end hardness` for each individual case.
PRESIDENT The Original wash materials are stable but also free-flowing under pressure to capture all details precisely. The hydrophilic properties are effected by surfactants in the material. In contact with moisture these additives move to the surface and decrease the surface tension, resulting in an improved wettability. Furthermore, new colors were added to provide a better contrast between wash and tray materials and to allow a more accurate detail readability.
PRESIDENT The Original family devices are addition type sillicone-based dental impression materials composed of polyvinylsiloxanes, addition type/surface silicone elastomers in various compositions to achieve different viscosities and flow properties depending on the intended use.
To start the curing process the base material needs to be mixed with the corresponding catalyst material. The setting occurs via an addition reaction. The base materials consist of polyvinylsiloxanes, inorganic silicon fillers and other additives (e.g. coloring pigments). In all PRESIDENT The Original family members, except the putty consistencies, surfactants are used to increase hydrophilicity of the impression material.
The document describes the acceptance criteria and the study conducted for the dental impression material, "PRESIDENT The Original," to demonstrate substantial equivalence to the predicate device, "Aquasil® Ultra+."
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states compliance with ISO 4823:2021, which sets forth the requirements and test methods for elastomeric impression materials. The specific acceptance criteria within this standard are not explicitly detailed in the provided text, nor are specific numerical performance values for each criterion. Instead, it states that the device "conforms with ISO 4823."
| Performance Characteristic (based on ISO 4823:2021) | Acceptance Criteria (from ISO 4823:2021 - not explicitly detailed in document, but implied by conformity) | Reported Device Performance (for PRESIDENT The Original) |
|---|---|---|
| Mixing time | Within specified limits for the material type | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Consistency | Within specified limits for the material type | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Working time | Within specified limits for the material type | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Detail reproduction | Meets minimum requirements for detail reproduction (e.g., reproduction of fine lines) | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Linear dimensional change | Within specified limits (e.g., maximum percentage change) | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Elastic recovery | Meets minimum percentage of elastic recovery | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Strain in compression | Within specified limits | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Compatibility with gypsum | Demonstrated compatibility with gypsum models | Not explicitly stated, but device was tested for this as per ISO 4823:2021 |
| Biocompatibility | Conforms with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Device demonstrated conformity through testing |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document states "extensive testing," but does not provide numbers for the test samples.
- Data Provenance: The testing was conducted by Coltène/Whaledent AG, based in Switzerland. The data is retrospective in the sense that the testing has already been completed to generate the submission data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The testing for dental impression materials is primarily objective, based on physical and mechanical properties measured in a laboratory setting according to international standards (ISO 4823). It does not involve human interpretation of images or clinical outcomes in the same way an AI diagnostic device would require experts to establish ground truth.
4. Adjudication method for the test set:
Not applicable, for the same reason as point 3. The performance is measured against standardized physical and mechanical properties.
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:
Not applicable. This is not an AI device or a diagnostic device involving human readers. It is a dental impression material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The device performance is assessed directly through laboratory testing of its physical and mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is defined by the objective, quantifiable physical and mechanical properties outlined in the international standard ISO 4823:2021, and biocompatibility standards (ISO 10993 series). These standards provide established methodologies and acceptance criteria for these properties.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 13, 2022
Coltène/Whaledent AG % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K220097
Trade/Device Name: PRESIDENT The Original Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: Class II Product Code: ELW Dated: January 7, 2022 Received: January 12, 2022
Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name PRESIDENT The Original
Indications for Use (Describe)
PRESIDENT The Original Xtra light body / light body / regular body:
- · Correction material for the corrective impression technique
- · Injection material for the double mix technique
- · Injection material for the dual arch technique»
- · Lining impression material
- PRESIDENT The Original heavy body:
- · Impression material for pick-up impression in the double mix technique
- · Tray material for corrective impression technique
- · Tray material for dual arch technique
PRESIDENT The Original System 360:
- · Impression material for pick-up impression in the double mix technique
- · Tray material for corrective impression technique
- · Tray material for dual arch technique
PRESIDENT The Original putty / putty soft / putty super soft / fast putty soft
- · Impression material for pick-up impression in the double mix technique
- · Tray material for corrective impression technique
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
{3}------------------------------------------------
K220097 510(k) Summary
5.1 Submitter
| Company Name: | Coltène/Whaledent AG |
|---|---|
| Street and Nr.: | Feldwiesenstrasse 20 |
| City: | Altstätten |
| Post Code: | 9450 |
| State/Canton: | St. Gallen |
| Country: | Switzerland |
5.2 Submitter contact:
| Regulatory contact: | Akanksha Nagpal Regulatory |
|---|---|
| Title: | Affairs Manager |
| Phone: | + 41 71 757 5385 |
| Email: | akanksha.nagpal@coltene.com |
5.3 Date prepared
31st March 2021
5.4 Device identification
| Trade Name: | PRESIDENT® The Original |
|---|---|
| Common Name: | addition type silicone-based impression materials for use in dentistry |
| Classification Name: | Impression material |
| Regulation Number: | 21 CFR 872.3660 |
| Product Code: | ELW |
| Class: | II |
| Classification Panel: | Dental |
5.5 Device overview
The subject device family is PRESIDENT The Original (Figure 1) which consists of addition type silicone based dental impression materials. PRESIDENT The Original is the relaunch and improved version of the predecessor device PRESIDENT (K811767), which is on the market since 1981.
PRESIDENT The Original is a two base system consisting of base and catalyst that are mixed together before use. The product portfolio of the subject device PRESIDENT The Original can be broadly subdivided into tray materials and wash materials, according to their physical and chemical properties.
{4}------------------------------------------------
LIENE
The tray materials have a higher tear strength and elasticity than the wash materials. PRESIDENT The Original System 360 devices are surface activated and thixotropic with fast pressure build up so that the wash material is driven into the clinically critical areas. PRESIDENT The Original putties are offered in three different end hardness` for each individual case.
PRESIDENT The Original wash materials are stable but also free-flowing under pressure to capture all details precisely. The hydrophilic properties are effected by surfactants in the material. In contact with moisture these additives move to the surface and decrease the surface tension, resulting in an improved wettability. Furthermore, new colors were added to provide a better contrast between wash and tray materials and to allow a more accurate detail readability.
Image /page/4/Picture/4 description: The image shows a collection of dental impression materials from the brand President. There are several boxes and containers of different sizes and shapes, arranged on a white surface. The boxes are mostly white with the brand name "PRESIDENT" printed on them, along with other product information. Some of the containers are cylindrical and have orange or blue labels.
Figure 1: Device family overview of the subject device PRESIDENT The Original.
5.6 Indication for use
PRESIDENT The Original Xtra light body / light body / regular body:
- Correction material for the corrective impression technique
- Injection material for the double mix technique
- Injection material for the dual arch technique»
- Lining impression material
{5}------------------------------------------------
PRESIDENT The Original heavy body:
- Impression material for pick-up impression in the double mix technique
- Tray material for corrective impression technique
- Tray material for dual arch technique
PRESIDENT The Original System 360:
- Impression material for pick-up impression in the double mix technique
- Tray material for corrective impression technique
- Tray material for dual arch technique
PRESIDENT The Original putty / putty soft / putty super soft / fast putty soft:
- Impression material for pick-up impression in the double mix technique
- · Tray material for corrective impression technique
5.7 Primary predicate device Aquasil® Ultra+ (K152861) by Dentsply Sirona
The primary predicate device chosen is Aquasil® Ultra+ by Dentsply Sirona. Aquasil® Ultra+ was cleared in March 2016 under the 510(k) number K152861 (Exhibit 5-1). Aquasil® Ultro+ putty regular and Aquasil® Ultra+ medium regular were chosen to claim substantial equivalence with the new device PRESIDENT® The Original. Aquasil® Ultra+ medium regular was chosen as the predicate device for PRESIDENT The Original Xtra light body, regular body, (System 360) MonoBody, (System 360) heavy body, heavy body and Aquasil® Ultra+ putty regular was chosen as the predicate device for PRESDIENT the Original putty, putty soft, putty super soft and fast putty soft.
5.8 PRESIDENT The Original chemical composition
PRESIDENT The Original family devices are addition type sillicone-based dental impression materials composed of polyvinylsiloxanes, addition type/surface silicone elastomers in various compositions to achieve different viscosities and flow properties depending on the intended use.
To start the curing process the base material needs to be mixed with the corresponding catalyst material. The setting occurs via an addition reaction. The base materials consist of polyvinylsiloxanes, inorganic silicon fillers and other additives (e.g. coloring pigments). In all PRESIDENT The Original family members, except the putty consistencies, surfactants are used to increase hydrophilicity of the impression material. An overview of the chemical composition of PRESIDENT The Original and Aquasil® Ultra+ is shown in Table 1.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for COLTENE. The logo consists of a blue graphic on the left and the word "COLTENE" in black on the right. The graphic is made up of nine squares arranged in three rows of three, with the squares in the bottom row being a lighter shade of blue than the squares in the top row.
Table 1: Chemical composition of PRESIDENT The Original compared to the predicate device Aquasil® Ultra+. A detailed chemical composition for the subject device is provided in Section 11 – Device Description).
| Chemical CompoundGroup | Subject Device:PRESIDENT The Original | Predicate Device:Aquasil® Ultra+medium regular | Predicate Device:Aquasil® Ultra+ puttyregular |
|---|---|---|---|
| Organopolysiloxanes | Divinylpolydimethylsiloxanes | Polydimethyle siloxanepolymerPolymethylhydrogensiloxane | Polyvinyl siloxaneMethylhydrogene siloxane |
| Inorganic filler | Silicon dioxideZeolite | Silicon dioxideSodium Aluminosilicate(Zeolite) | Silicon dioxide- |
| Organic platinumcatalyst | Platinum(0)-1,3-divinyl-1,1,3,3-tetramethyldisiloxane complexsolution | Organic PlatinumComplex | Organic Platinum Complex |
| Surfactants | Surfactant (except in putties) | Surfactant | - |
| Pigments | Titanium DioxideIron Oxide PigmentsOrganic Pigments | Titanium DioxideFluorescent PigmentsMetallic OxidePigmentsIron Oxide PigmentsOrganic Pigments | Pigments |
| Flavour | - | Peppermint Oil | - |
PRESIDENT The Original and Aquasil® Ultra+ devices are classified as surface-contacting medical devices according to ISO 10993-1:2018 Section 5.2.2 and have a short-term contact (<24 h) with tissue and dentin.
5.9 Substantial Equivalence Discussion
A comparison of the subject device PRESIDENT The Original and the primary predicate device Aquasil® Ultra+, with respect to their physical state, structure, materials, mechanical properties, indications for use, packaging, biocompatibility and performance testing, is shown in Table 2.
Table 2: Comparison of device characteristics of the subject device PRESIDENT The Original and the predicate device Aquasil® Ultra+.
| Attributes | Predicate Device | Predicate Device | Subject Device | Similarities /Differences |
|---|---|---|---|---|
| Aquasil® Ultra+medium regular | Aquasil® Ultra+ puttyregular | PRESIDENT TheOriginal | ||
| Device Name | Aquasil® Ultra+medium regular | Aquasil® Ultra+ puttyregular | PRESIDENT TheOriginal | - |
| Manufacturer | Dentsply Caulk,Milford DE, USA | Dentsply Caulk,Milford DE, USA | Coltène/WhaledentAG, Switzerland | - |
| 510(k) Number | K152861 | K152861 | Pending | - |
| Attributes | Predicate Device | Predicate Device | Subject Device | Similarities /Differences |
| Aquasil® Ultra+medium regular | Aquasil® Ultra+ puttyregular | PRESIDENT TheOriginal | ||
| Product Code | ELW | ELW | ELW | |
| Regulation | 872.3660 | 872.3660 | 872.3660 | Same |
| Class | II | II | II | Same |
| Review Panel | Dental | Dental | Dental | Same |
| Device Image | Image: Aquasil Ultra+ medium regular | Image: Aquasil Ultra+ putty regular | Image: PRESIDENT The Original | |
| Image: PRESIDENT The Original Xtra light body, light body, regular bodyImage: PRESIDENT The Original MonoBody / heavy bodyImage: PRESIDENT The Original Putties | ||||
| Indications forUse | Aquasil® Ultra+Material is indicatedfor all dentalimpressiontechniques. | Aquasil® Ultra+ Puttymaterials are thick,vinyl polysiloxanedental impressionmaterialsintended to be usedin conjunction withmore fluid vinylpolysiloxaneimpression materialsin order to makeimpressions. Theresulting impressionsare used to makeplaster modelsof the teeth. | Xtra light body / lightbody / regular body:• Correction materialfor the correctiveimpression technique• Injection material forthe double mixtechnique• Injection material forthe dual archtechnique»• Lining impressionmaterialheavy body:• Impression material | The subject andpredicate device havethe same intendeduse. Both devices areused for dentalimpression techniquesaccording to theirconsistencies. |
| Attributes | Predicate DeviceAquasil® Ultra+medium regular | Predicate DeviceAquasil® Ultra+ puttyregular | Subject DevicePRESIDENT TheOriginal | Similarities /Differences |
| in the double mixtechnique• Tray material forcorrective impressiontechnique• Tray material for dualarch techniqueSystem 360:• Impression materialfor pick-up impressionin the double mixtechnique• Tray material forcorrective impressiontechnique• Tray material for dualarch technique | ||||
| putty / putty soft /putty super soft / fastputty soft:• Impression materialfor pick-up impressionin the double mixtechnique• Tray material forcorrective impressiontechnique | ||||
| Physical State | Viscous pastes withvarious viscosity andputties with variouselasticities | Viscous pastes withvarious viscosity andputties with variouselasticities | Viscous pastes withvarious viscosity andputties with variouselasticities | The subject andpredicate devices areprovided as viscouspastes with variousviscosities and puttieswith variouselasticities.The physical states aresimilar. |
| Structure | Addition type siliconebased elastomericimpression materials | Addition type siliconebased elastomericimpression materials | Addition type siliconebased elastomericimpression materials | The subject and thepredicate device aresupplied as pastes andputties. The newdevice and itspredecessor differslightly in composition,physical properties andcolor. |
| Packaging | Primary packagingTubes, Pots orcartridges | Primary packaging:Tubes, Pots orcartridges | Primary packaging:Tubes, Pots orcartridges | The subject andpredicate device arepackaged the sameway according to theirphysical state. |
| Secondary packaging: | Secondary packaging: | Secondary packaging: | ||
| Attributes | Predicate Device | Predicate Device | Subject Device | Similarities /Differences |
| Aquasil® Ultra+medium regular | Aquasil® Ultra+ puttyregular | PRESIDENT TheOriginal | ||
| Folding carton | Folding carton | Folding carton | ||
| Usage | Single patient, singleuse.Not reusable | Single patient, singleuse.Not reusable | Single patient, singleuse.Not reusable | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Handling System | Two partbase/catalyst system | Two partbase/catalyst system | Two part base/catalystsystem | Same |
| Type ofCuring | Self-curing aftermixing of base andcatalyst part. | Self-curing aftermixing of base andcatalyst part. | Self-curing after mixingof base and catalystpart. | Same |
| Biocompatibility | Conforms withISO 10993-1 | Conforms withISO 10993-1 | Conforms withISO 10993-1 | Same |
| Performance | Conforms with ISO4823 | Conforms with ISO4823 | Conforms with ISO4823 | Same |
{7}------------------------------------------------
Coltène/Whaledent AG Traditional 510(k) Premarket Notification PRESIDENT The Original
Image /page/7/Picture/1 description: The image shows the logo for COLTENE. The logo consists of a blue graphic on the left and the word "COLTENE" in black, bold letters on the right. The graphic is made up of six blue squares arranged in two rows of three, with the squares in the bottom row being a lighter shade of blue than the squares in the top row.
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for COLTENE. The logo consists of a blue graphic on the left and the word "COLTENE" in black, bold letters on the right. The graphic is made up of six blue squares arranged in two rows of three, with the squares in the bottom row being a lighter shade of blue.
{9}------------------------------------------------
5.10 Non-Clinical Performance Data
As part of demonstrating substantial equivalence of PRESIDENT The Original to the predicate device Aquasil® Ultra+ (K152861), Coltène/Whaledent AG has performed extensive testing of the finished device in accordance with the applicable parts of the following voluntary standards, or according to the company's own internal test protocols.
- . ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
- ISO 4823:2021: Dentistry -- Elastomeric impression materials
- . ISO 15223-1:2016 Medical devices – Symbols to be used with medical devices labels, labeling, and information to be supplied – Part 1: General requirements.
- ISO 7405:2018 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
- ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- . ISO/TR 10993-22:2017 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
- . FDA General Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", September 4, 2020.
- . ISO 14971:2019 Medical devices - Application of risk management to medical devices
- . ISO 82079-1:2012: Preparation of information for use (instructions for use) of products - Part 1: Principles and general requirements
- IEC 62366-1:2015: Medical devices - Part 1: Application of usability engineering to medical devices
{10}------------------------------------------------
- IEC/TR 62366-2:2016: Medical devices Part 2: Guidance on the application of usability engineering to ● medical devices
The device testing evaluated mixing time, consistency, working time, detail reproduction, , linear dimensional change, elastic recovery, strain in compression, and compatibility with gypsum according to ISO 4823:2021. Also an extensive biocompatibility testing according to ISO 10993-1 was conducted.
5.11 Statement of Substantial Equivalence
PRESIDENT The Original has the same intended use, indications for use and similar chemical and physical attributes as the predicate device Aquasil® Ultra+ (K152861) (with consistencies ranging from putties to light body consistencies). Any minor differences in the used materials and compositions to make the subject device, when compared to the predicate device have been successfully evaluated by Coltène/Whaledent AG through performance and biocompatibility testing on the subject device. The information submitted to the FDA demonstrates that the subject device is as safe and as effective as the predicate device and does not raise any new questions or concerns regarding safety and effectiveness. In conclusion the subject device PRESIDENT The Original has been determined to be substantially equivalent to the predicate device Aquasil® Ultra+ (K152861).
§ 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).