PRESIDENT The Original

K220097 · Coltène/Whaledent AG · ELW · Jan 13, 2022 · Dental

Device Facts

• Record ID: K220097
• Device Name: PRESIDENT The Original
• Applicant: Coltène/Whaledent AG
• Product Code: ELW · Dental
• Decision Date: Jan 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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 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

Device Story

PRESIDENT The Original is an addition-type silicone-based dental impression material system. It consists of a two-part base and catalyst system mixed by the clinician prior to use. The material is available in various viscosities (putty to light body) and is used to capture precise dental details for models. The system includes tray materials (higher tear strength/elasticity) and wash materials (hydrophilic, free-flowing under pressure). Surfactants in wash materials improve wettability in moist environments. The device is used in dental clinics by dental professionals. The resulting impression is used by the clinician to create accurate plaster models of the patient's teeth, facilitating restorative or diagnostic dental decision-making.

Clinical Evidence

Bench testing only. Testing performed per ISO 4823:2021 (mixing time, consistency, working time, detail reproduction, linear dimensional change, elastic recovery, strain in compression, gypsum compatibility) and ISO 10993-1 (biocompatibility). No clinical data presented.

Technological Characteristics

Addition-type silicone (polyvinylsiloxane) elastomer. Components: divinylpolydimethylsiloxanes, inorganic fillers (silicon dioxide, zeolite), platinum catalyst, surfactants (except in putties), pigments. Viscosities range from putty to light body. Non-sterile, single-use. Conforms to ISO 4823:2021 and ISO 10993-1:2018.

Indications for Use

Indicated for dental impression procedures, including corrective, double mix, dual arch, and pick-up techniques, and as a lining material. Used for making dental impressions to create plaster models of teeth.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Aquasil® Ultra+ (K152861)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K220097

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)

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## 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: | [e-mail] |

## 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.

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# 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

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### 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.

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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 Compound<br>Group | Subject Device:<br>PRESIDENT The Original | Predicate Device:<br>Aquasil® Ultra+<br>medium regular | Predicate Device:<br>Aquasil® Ultra+ putty<br>regular |
|------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Organopolysiloxanes | Divinylpolydimethylsiloxanes | Polydimethyle siloxane<br>polymer<br>Polymethylhydrogen<br>siloxane | Polyvinyl siloxane<br>Methylhydrogene siloxane |
| Inorganic filler | Silicon dioxide<br>Zeolite | Silicon dioxide<br>Sodium Aluminosilicate<br>(Zeolite) | Silicon dioxide<br>- |
| Organic platinum<br>catalyst | Platinum(0)-1,3-divinyl-1,1,3,3-<br>tetramethyldisiloxane complex<br>solution | Organic Platinum<br>Complex | Organic Platinum Complex |
| Surfactants | Surfactant (except in putties) | Surfactant | - |
| Pigments | Titanium Dioxide<br><br>Iron Oxide Pigments<br>Organic Pigments | Titanium Dioxide<br>Fluorescent Pigments<br>Metallic Oxide<br>Pigments<br>Iron Oxide Pigments<br>Organic 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 /<br>Differences |
|------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Aquasil® Ultra+<br>medium regular | Aquasil® Ultra+ putty<br>regular | PRESIDENT The<br>Original | |
| Device Name | Aquasil® Ultra+<br>medium regular | Aquasil® Ultra+ putty<br>regular | PRESIDENT The<br>Original | - |
| Manufacturer | Dentsply Caulk,<br>Milford DE, USA | Dentsply Caulk,<br>Milford DE, USA | Coltène/Whaledent<br>AG, Switzerland | - |
| 510(k) Number | K152861 | K152861 | Pending | - |
| Attributes | Predicate Device | Predicate Device | Subject Device | Similarities /<br>Differences |
| | Aquasil® Ultra+<br>medium regular | Aquasil® Ultra+ putty<br>regular | PRESIDENT The<br>Original | |
| 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 body<br><br>Image: PRESIDENT The Original MonoBody / heavy body<br><br>Image: PRESIDENT The Original Putties | |
| Indications for<br>Use | Aquasil® Ultra+<br>Material is indicated<br>for all dental<br>impression<br>techniques. | Aquasil® Ultra+ Putty<br>materials are thick,<br>vinyl polysiloxane<br>dental impression<br>materials<br>intended to be used<br>in conjunction with<br>more fluid vinyl<br>polysiloxane<br>impression materials<br>in order to make<br>impressions. The<br>resulting impressions<br>are used to make<br>plaster models<br>of the teeth. | Xtra light body / light<br>body / regular body:<br>• Correction material<br>for the corrective<br>impression technique<br>• Injection material for<br>the double mix<br>technique<br>• Injection material for<br>the dual arch<br>technique»<br>• Lining impression<br>material<br><br>heavy body:<br>• Impression material | The subject and<br>predicate device have<br>the same intended<br>use. Both devices are<br>used for dental<br>impression techniques<br>according to their<br>consistencies. |
| Attributes | Predicate Device<br>Aquasil® Ultra+<br>medium regular | Predicate Device<br>Aquasil® Ultra+ putty<br>regular | Subject Device<br>PRESIDENT The<br>Original | Similarities /<br>Differences |
| | | | in the double mix<br>technique<br>• Tray material for<br>corrective impression<br>technique<br>• Tray material for dual<br>arch technique<br><br>System 360:<br>• Impression material<br>for pick-up impression<br>in the double mix<br>technique<br>• Tray material for<br>corrective impression<br>technique<br>• Tray material for dual<br>arch technique | |
| | | | putty / putty soft /<br>putty super soft / fast<br>putty soft:<br>• Impression material<br>for pick-up impression<br>in the double mix<br>technique<br>• Tray material for<br>corrective impression<br>technique | |
| Physical State | Viscous pastes with<br>various viscosity and<br>putties with various<br>elasticities | Viscous pastes with<br>various viscosity and<br>putties with various<br>elasticities | Viscous pastes with<br>various viscosity and<br>putties with various<br>elasticities | The subject and<br>predicate devices are<br>provided as viscous<br>pastes with various<br>viscosities and putties<br>with various<br>elasticities.<br>The physical states are<br>similar. |
| Structure | Addition type silicone<br>based elastomeric<br>impression materials | Addition type silicone<br>based elastomeric<br>impression materials | Addition type silicone<br>based elastomeric<br>impression materials | The subject and the<br>predicate device are<br>supplied as pastes and<br>putties. The new<br>device and its<br>predecessor differ<br>slightly in composition,<br>physical properties and<br>color. |
| Packaging | Primary packaging<br>Tubes, Pots or<br>cartridges | Primary packaging:<br>Tubes, Pots or<br>cartridges | Primary packaging:<br>Tubes, Pots or<br>cartridges | The subject and<br>predicate device are<br>packaged the same<br>way according to their<br>physical state. |
| | Secondary packaging: | Secondary packaging: | Secondary packaging: | |
| Attributes | Predicate Device | Predicate Device | Subject Device | Similarities /<br>Differences |
| | Aquasil® Ultra+<br>medium regular | Aquasil® Ultra+ putty<br>regular | PRESIDENT The<br>Original | |
| | Folding carton | Folding carton | Folding carton | |
| Usage | Single patient, single<br>use.<br>Not reusable | Single patient, single<br>use.<br>Not reusable | Single patient, single<br>use.<br>Not reusable | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Handling System | Two part<br>base/catalyst system | Two part<br>base/catalyst system | Two part base/catalyst<br>system | Same |
| Type of<br>Curing | Self-curing after<br>mixing of base and<br>catalyst part. | Self-curing after<br>mixing of base and<br>catalyst part. | Self-curing after mixing<br>of base and catalyst<br>part. | Same |
| Biocompatibility | Conforms with<br>ISO 10993-1 | Conforms with<br>ISO 10993-1 | Conforms with<br>ISO 10993-1 | Same |
| Performance | Conforms with ISO<br>4823 | Conforms with ISO<br>4823 | Conforms with ISO<br>4823 | Same |

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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.

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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.

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### 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

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- 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).