EDS Calculus Softener TURBO CR

K223340 · Essential Dental Systems, Inc. · ELC · Dec 11, 2023 · Dental

Device Facts

• Record ID: K223340
• Device Name: EDS Calculus Softener TURBO CR
• Applicant: Essential Dental Systems, Inc.
• Product Code: ELC · Dental
• Decision Date: Dec 11, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.

Device Story

EDS Calculus Softener (TURBO-CR) is a professional-use dental gel/paste used by dental hygienists to facilitate calculus removal. The device consists of two component pastes housed in a dual-barrel syringe. Upon expression through a mixing tip, the pastes combine to form an effervescent foam. This foam is dispensed into a dental tray, which is placed over the patient's dental arch for 60 seconds. The effervescence drives the composition—containing chelating agents and detergents—into interproximal and subgingival spaces to soften mineralized plaque, calculus, and tartar. After contact, the patient rinses, and the hygienist performs manual or ultrasonic scaling. The device reduces scaling time and aids in removing etiological factors of periodontal disease. It is non-sterile and does not contain fluoride or whitening agents.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (ASTM E384-22, ISO 11609:2017, ISO 3219-2:2021) and biocompatibility testing (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 7405).

Technological Characteristics

Dual-barrel syringe delivery system; chemical composition includes chelating agents, detergents, sodium bicarbonate, and gelling agents. Physical properties tested per ASTM E384-22 (microindentation hardness), ISO 11609:2017 (pH), and ISO 3219-2:2021 (viscosity). Non-sterile, professional-use gel.

Indications for Use

Indicated for dental patients requiring professional cleaning and removal of dental plaque, mineralized calculus, and/or tartar from subgingival root surfaces and supragingival areas.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

• SofScale (K903163)
• Therasol Tartar Dissolver (510k Exempt)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 11, 2023

Essential Dental Systems Inc. Jason Guzman R&D Manager 89 Leuning Street South Hackensack, New Jersey 07606

Re: K223340

Trade/Device Name: EDS Calculus Softener (TURBO-CRTM) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: November 14, 2023 Received: November 15, 2023

Dear Jason Guzman:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

# Michael E. Adjodha -S

Michael Adjodha, MChE, RAC, CQIA 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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# Indications for Use

510(k) Number (if known)

K 2 2 3 3 4 0

Device Name

EDS Calculus Softener (TURBO-CR™)

### Indications for Use (Describe)

Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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Image /page/4/Picture/0 description: The image shows the logo for Essential Dental Systems. The logo is in blue and consists of the letters "EDS" in a bold, stylized font. To the right of the letters is the text "ESSENTIAL DENTAL SYSTEMS" in a smaller, sans-serif font. The logo is enclosed in a rounded rectangle, and below the rectangle is the text "© Essential Dental Systems, Inc."

# Section 5 - 510(k) Summary

[21 CFR 807.92 (c)]

| <b>5.1. Application Information:</b> | [807.92 (a)(1)] | | |
|--------------------------------------------------------------|---------------------------------------------------------------------------------|----|-------------------------------|
| <b>Date Prepared:</b> | May 11, 2023 | | |
| <b>Company Name and Address:</b> | Essential Dental Systems, inc.<br>89 Leuning Street, South Hackensack, NJ 07606 | | |
| <b>Contact:</b> | Mr. Jason Guzman | OR | Ms. Shamal Kadam |
| <b>Designation:</b> | R&D Manager | | Regulatory Affairs Specialist |
| <b>Email:</b> | [e-mail] | | [e-mail] |
| <b>Phone #:</b> | 201-487-9090 ext.119 | | 201-487-9090 ext.114 |
| <b>Fax #:</b> | 201-487-5120 | | 201-487-5120 |
| <b>List of devices for which<br/>clearance is requested:</b> | A scaler/periodontal debriding gel called EDS Calculus Softener<br>(TURBO-CRTM) | | |

### 5.2. Name of the Device: [807.92 (a)(2)]

| Trade name: | EDS Calculus Softener (TURBO-CR™) |
|-------------------------|-------------------------------------------|
| Device Type: | Scaler/periodontal debriding solution/gel |
| Regulation Description: | A periodontal debriding solution/gel |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.4850 (Scaler) |
| Device class: | Class II |
| Product Code: | ELC |

#### 5.3. Predicate Device Information: [807.92 (a)(3)]

The legally marketed devices to which substantial equivalence is being claimed are:

| | Primary predicate device | Reference Predicate device |
|-------------------|-----------------------------------------------|----------------------------|
| Device | SofScale – Periodontal debriding solution/gel | Therasol Tartar Dissolver |
| Manufacturer | Dentsply | OraTec |
| 510K number | K903163 | 510k Exempt |
| Regulation Number | 21 CFR 872.4850 | 21 CFR 872.4850 |
| Product Code | ELC | ELC |

Table 5.1 – Predicate Devices

NOTE: The Predicate device has not been subject to a design-related recall.

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Image /page/5/Picture/0 description: The image shows the logo for Essential Dental Systems, Inc. The logo includes the letters "EDS" in a stylized blue font, along with the words "ESSENTIAL DENTAL SYSTEMS" in a smaller font. Below the logo is the company name and address: "89 Leuning Street, South Hackensack, NJ 07606".

#### 5.4. Device Description: [807.92 (a)(4)]

EDS Calculus Softener (TURBO-CR™) is a professional use only product to be used by a dental hygienist to aid in the cleaning and removal of dental plaque, mineralized calculus and/or tartar from subgingival root surfaces and supragingival areas of teeth. The composition helps remove the etiological factors which have been implicated in fostering periodontal disease. The device contains chelating agents and detergents which reduce the hardness of mineralized plaque, calculus, and/or tartar. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. The device contains an alkaline paste which effervescences or foams upon mixing through a mixing tip. This effervescence helps drive the activated composition into the "hard to reach" interproximal spaces between teeth as into the subgingival regions where tartar/plaque and or dental calculus can accumulate.

It is packaged in the familiar double-barrel syringe configuration used by numerous other dental materials. The double barrel syringe is placed into a manual cartridge gun (commonly available at the dental clinic) and the composition is dispensed into a dental tray which is then placed over the patient's dental arch for cleaning. The steps required to properly express the calculus softening composition are: remove cap, attach mixer, place into manual cartridge gun, express the material into a dental tray, and then place into the patient's mouth over the dental arch to be cleaned/debrided for 60 seconds. The patient is then instructed to rinse and the dental scaling can commence by the dental hygienist. After use, the mixer/dispensing tip and dental tray should be discarded and the cap replaced. The device is provided non-sterile and does not contain fluoride or any whitening agents.

# 5.5. Device Configuration: [807.92 (a)(4)]

The device configuration is:

### Table 5.2 – Device Contents

| Contents | Amount |
|----------------------------------------------------------------------------------------|--------|
| Dual chambered syringes each containing 30 or 75 gm periodontal debriding solution/gel | 1 |
| Mixer tips | 15 |

#### 5.6. Device Composition:

- * Paste/Gel 1:
- a. Water
- b. Glycerol
- Polyethylene Glycol (MW 600) ن
- d. Sodium Dodecyl Sulfate
- e. Xanthan Gum
- f. Hydrated Silica

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Image /page/6/Picture/0 description: The image is a logo for Essential Dental Systems. The logo is blue and white and features the letters "EDS" in a stylized font. To the right of the letters is the text "ESSENTIAL DENTAL SYSTEMS". The logo is surrounded by a rounded rectangle. Below the logo is the text "© Essential Dental Systems, Inc."

Essential Dental Systems, in 89 Leuning Street, South Hackensack, NJ 07606

- Sodium Saccharin g.
- h. Sodium Dihydrogen Phosphate
- k. FD&C Blue 1
- Paste/Gel 2: જુન
- a. Water
- b. Glycerol
- Polyethylene Glycol (MW 600) C.
- Sodium Dodecyl Sulfate d.
- e. Peppermint Oil
- f. Xanthan Gum
- i. Phosphoric Acid
- j. Sodium Acid Pyrophosphate
- Hydrated Silica g.
- h. Sodium Bicarbonate
- i. Sodium Saccharine
- Tetrasodium Pyrophosphate j.
- k. FD&C Yellow 5

#### Intended Use / Indication for Use: [807.92 (a)(5)] 5.7.

Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.

#### 5.8. Substantial Equivalence Discussion: [807.92 (a)(6)]

A comparison of EDS Calculus Softener (TURBO-CR™) and the predicate devices indicates the following similarities and differences to the devices which received 510(k) clearance:

| | Proposed Device | Primary Predicate Device | Reference Predicate Device |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | EDS Calculus Softener<br>(TURBO-CRTM) | SofScale | Therasol Tartar Dissolver |
| 510(k)<br>Number | K223340 (under review) | K903163 | 510k Exempt |
| Manufacturer | Essential Dental Systems | Dentsply | OraTec |
| Indications for<br>Use | Softens dental calculus / tartar<br>/ plaque to facilitate easier<br>removal;<br>Reduces scaling time;<br>May be used in hand and<br>ultrasonic scaling procedures | Softens calculus to facilitate<br>easier removal;<br>Reduces scaling time;<br>May be used in hand and<br>ultrasonic scaling<br>procedures | indicated to aid in the<br>removal or debridment of<br>dental calculus, plaque or<br>tartar. |
| | Proposed Device | Primary Predicate Device | Reference Predicate Device |
| Composition | Paste/Gel 1 - Water, Glycerol,<br>Polyethylene Glycol (MW<br>600), Sodium Dodecyl Sulfate,<br>Xanthan Gum, Hydrated<br>Silica, Sodium Saccharin,<br>Sodium Dihydrogen<br>Phosphate, Phosphoric Acid,<br>Sodium Acid Pyrophosphate,<br>FD&C Blue 1.<br>Paste/Gel 2 - Water, Glycerol,<br>Polyethylene Glycol (MW<br>600), Sodium Dodecyl Sulfate,<br>Peppermint Oil, Xanthan<br>Gum, Hydrated Silica, Sodium<br>Bicarbonate, Sodium<br>Saccharine, Tetrasodium<br>Pyrophosphate FD&C Yellow<br>5. | Paste/Gel Water,<br>Denatured Ethyl Alcohol,<br>Hydroxyethylcellulose,<br>Sodium<br>Ethylenediaminetetraacetic<br>Acid (EDTA), Polysorbate<br>80, Sodium Lauryl Sulfate,<br>Sodium Bicarbonate,<br>Flavor, Aspartame, FD&C<br>Green #3. | Water, Tetrapotassium<br>Pyrophosphate, Sodium<br>Tripolyphosphate, Sodium<br>Bicarbonate, Citric Acid And<br>Sodium Fluoride. |
| Color | Paste 1 Yellow,<br>Paste 2 Blue,<br>Green upon mixing. | Green | Colorless |
| Patient<br>Contacting<br>Material(s) | Gel/Paste 1 - Water, Glycerol,<br>Polyethylene Glycol (MW<br>600), Sodium Dodecyl Sulfate,<br>Xanthan Gum, Hydrated<br>Silica, Sodium Saccharin,<br>Sodium Dihydrogen<br>Phosphate, Phosphoric Acid,<br>Sodium Acid Pyrophosphate,<br>FD&C Blue 1.<br>Gel/Paste 2 - Water, Glycerol,<br>Polyethylene Glycol (MW<br> | Water, Denatured Ethyl<br>Alcohol,<br>Hydroxyethylcellulose,<br>Sodium<br>Ethylenediaminetetraacetic<br>Acid (EDTA), Polysorbate<br>80, Sodium Lauryl Sulfate,<br>Sodium Bicarbonate,<br>Flavor, Aspartame, FD&C<br>Green #3. | Water, Tetrapotassium<br>Pyrophosphate, Sodium<br>Tripolyphosphate, Sodium<br>Bicarbonate, Citric Acid And<br>Sodium Fluoride. |
| | Proposed Device | Primary Predicate Device | Reference Predicate Device |
| | 600), Sodium Dodecyl Sulfate,<br>Peppermint Oil, Xantham<br>Gum, Hydrated Silica, Sodium<br>Bicarbonate, Sodium<br>Saccharine, Tetrasodium<br>Pyrophosphate FD&C Yellow<br>5. | | |
| Device<br>Description | EDS Calculus Softener<br>(TURBO-CRTM) is a<br>professional use only product<br>to be used by a dental<br>hygienist to aid in the<br>cleaning and removal of<br>dental plaque and<br>mineralized calculus or tartar.<br>The device contains chelating<br>agents and detergents which<br>reduce the hardness of or<br>soften mineralized plaque,<br>calculus, and/or tartar. | Dentsply SofScale is a<br>professional use only<br>product to be used by a<br>dental hygienist to aid in<br>the cleaning and removal<br>of dental plaque and<br>mineralized calculus or<br>tartar. The device contains<br>chelating agents and<br>detergents which reduce<br>the hardness of or soften<br>mineralized plaque,<br>calculus, and/or tartar. | Therasol Tartar Dissolver is<br>an over the counter use<br>product that is designed to<br>loosen, soften, or partially<br>dissolve dental calculus,<br>plaque and/or tartar<br>between dental visits. The<br>device contains chelating<br>agents and sodium<br>bicarbonate which reduce<br>the hardness of or soften<br>mineralized plaque,<br>calculus, and/or tartar. |
| Picture of<br>Device | Image: TURBO-CR product | Image: SofScale product | Image: TheraSol Tartar Dissolver product |
| Intended Use | Softens calculus, tartar, or<br>plaque to facilitate easier<br>removal; Reduces scaling<br>time; May be used in hand<br>and ultrasonic scaling<br>procedures. | Softens calculus, tartar, or<br>plaque to facilitate easier<br>removal; Reduces scaling<br>time; May be used in hand<br>and ultrasonic scaling<br>procedures. | Softens calculus, tartar, or<br>plaque to facilitate easier<br>removal; Reduces scaling<br>time in between office<br>visits; May be used in hand<br>and ultrasonic scaling<br>procedures. |
| | Proposed Device | Primary Predicate Device | Reference Predicate Device |
| Technology<br>Comparison | The dual gel/paste<br>composition contains<br>chelating agents, detergents,<br>mild abrasives, sodium<br>bicarbonate, gelling agents,<br>and flavoring that are mixed<br>upon delivery into a dental<br>tray via a double barrel<br>syringe. Upon mixing of the<br>two pastes, the material<br>forms a penetrating foam that<br>is driven into the "hard to<br>reach" interproximal areas<br>between teeth and<br>subgingivally to aid in the<br>removal of dental calculus,<br>tartar, and/or plaque. The<br>material is allowed to contact<br>the gumline for 1 minute<br>before rinsing and scaling by<br>the dental hygienist. | The single gel/paste<br>composition contains<br>chelating agents,<br>detergents, sodium<br>bicarbonate, gelling agents,<br>flavoring, and an organic<br>solvent (ethyl alcohol) that<br>is delivered via a single<br>barrel syringe directly to<br>the gum line. The material<br>is allowed to contact the<br>gumline for 1 minute<br>before scaling by the<br>dental hygienist. | The composition, a powder<br>containing chelating agents,<br>sodium bicarbonate, and<br>sodium fluoride, is mixed<br>with water before rinsing<br>for 1 minute in order to<br>soften dental calculus,<br>plaque, and/or plaque.<br>Brushing is then performed<br>in order to remove the<br>softened dental calculus,<br>tartar, and/or plaque. This<br>process is performed daily<br>in order to reduce dental<br>calculus, tartar , and/or<br>plaque in between dental<br>visits. |
| Differences* | The EDS Calculus Softener<br>(TURBO-CR™) is a two<br>component gel/paste<br>composition that effervesces<br>/foams upon mixing which<br>allows for penetration of the<br>material into the hard to<br>reach areas. A color change<br>when the two pastes are<br>combined ensure proper<br>mixing of the two<br>components. This device is for<br>professional use only. | SofScale is a single<br>gel/paste composition<br>delivered in a single barrel<br>syringe. This device is for<br>professional use only. This<br>device does not contain<br>fluoride. | Therasol Tartar Dissolver is<br>a powder composition that<br>is mixed with water before<br>rinsing. This composition is<br>an over the counter device. |

## Table 5.3 - Comparison of Characteristics

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Image /page/7/Picture/0 description: The image shows the logo for Essential Dental Systems. The logo is in a blue rounded rectangle. The letters "EDS" are in a large, bold font on the left side of the logo, and the words "ESSENTIAL DENTAL SYSTEMS" are in a smaller font on the right side. The copyright symbol and the words "Essential Dental Systems, Inc." are at the bottom of the logo.

Essential Dental Systems, inc. 89 Leuning Street, South Hackensack, NJ 07606

# Submission Number: K223340 EDS Calculus Softener (TURBO-CR™) Traditional 510(k) — Original

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Image /page/8/Picture/0 description: The image is a logo for Essential Dental Systems. The logo is blue and white and features the letters "EDS" in a stylized font. To the right of the letters is the text "ESSENTIAL DENTAL SYSTEMS". Below the logo is the text "© Essential Dental Systems, Inc."

Essential Dental Systems, inc. 89 Leuning Street, South Hackensack, NJ 07606

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Image /page/9/Picture/0 description: The image is a logo for Essential Dental Systems. The logo is blue and white and features the letters "EDS" in a stylized font. To the right of the letters is the text "ESSENTIAL DENTAL SYSTEMS". The logo is surrounded by a rounded rectangle. At the bottom of the logo is the text "© Essential Dental Systems, Inc."

Essential Dental Systems, inc. 89 Leuning Street, South Hackensack, NJ 07606

# Submission Number: K223340 EDS Calculus Softener (TURBO-CR™) Traditional 510(k) — Original

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Image /page/10/Picture/0 description: The image shows the logo and contact information for Essential Dental Systems, Inc. The logo features the letters "EDS" in a bold, blue font, along with the words "ESSENTIAL DENTAL SYSTEMS" in smaller font. The address is listed as 89 Leuning Street, South Hackensack, NJ 07606.

The EDS Calculus Softener (TURBO-CR™) is substantially equivalent to the primary predicate device, SofScale (#K903163) and reference predicate device Therasol Tartar Dissolver (510k exempt). These compositions are intended for use as water-based external communicating devices designed for an equivalent dental application, to aid in calculus/tartar/plaque removal, and have comparable physical properties, performance specifications and share several specific chemical components. The duration of contact for both devices is short term (<24 hrs). The maximum contact duration of the device in question is 2 minutes at maximum. The principal composition of the EDS Calculus Softener (TURBO-CR™) is substantially equivalent to the commercially available predicate devices, SofScale (#K903163) and TheraSol Tartar dissolver (510k exempt) in that the main ingredient that facilitates the primary function of these devices is the incorporation of a chelating agent capable of sequestering ions comprising dental calculus, plaque, and or tartar. Each of the aforementioned predicate devices contain specific chemical components that are identical or equivalent to those found in the EDS Calculus Softener (TURBO-CR™). All of the components found in the predicate devices have been used in legally marketed devices and were found safe for dental use. Additionally, several of the components of all of the aforementioned devices/products including the EDS Calculus Softener (TURBO-CR™), are also found in the FDA generally recognized as safe (GRAS) database. A search of the FDA MAUDE database yielded no adverse events for the cited predicate device, SofScale (#K903163). We believe that prior use of components in legally marketed devices, the performance and biocompatibility data provided support the safety and effectiveness of the EDS Calculus Softener (TURBO-CR™) for the indicated use. The device is provided non-sterile and does not contain fluoride or any whitening agents.

The subject device is substantially equivalent to SofScale (#K903163) and TheraSol Tartar Dissolver (510k exempt) in that they are primarily comprised of chelating agents, sodium bicarbonate, gelling agents, and flavoring. The indications for use for the subject device, The EDS Calculus Softener (TURBO-CR™), and the primary predicate device, SofScale (#K903163) are substantially equivalent. Both devices are for professional use only. From a material composition indication for use, and equivalent dental application perspective, TheraSol Tartar Dissolver is substantially equivalent to the aforementioned devices despite some differences (TheraSol Tartar Dissolver is over the counter use).

The EDS Calculus Softener (TURBO-CR™) and the primary predicate device, SofScale (#K903163) are available as syringeable gels/pastes essentially designed for equivalent dental applications and have equivalent physical properties and performance specifications. The principal composition of the EDS Calculus Softener (TURBO-CR™) is substantially equivalent to SofScale (#K903163). An additional reference predicate device includes TheraSol Tartar Dissolver (510k exempt) which contains specific chemical components that are equivalent to those found in the EDS Calculus Softener (TURBO-CR™), providing evidence that these chemical components are safe and effective for medical device use.

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Image /page/11/Picture/0 description: The image shows the logo for Essential Dental Systems, Inc. The logo includes the letters "EDS" in a blue box, followed by the words "ESSENTIAL DENTAL SYSTEMS" in a smaller font. Below the logo is the company name and address: 89 Leuning Street, South Hackensack, NJ 07606.

Furthermore, the EDS Calculus Softener (TURBO-CR™) and SofScale (#K903163) have comparable delivery systems in that they are applied via syringe.

### 5.9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: [807.92 (b)(1)]

The EDS Calculus Softener (TURBO-CR™) has undergone extensive bench and biocompatibility testing to provide evidence that the physical and chemical properties of the composition are substantially equivalent to the primary predicate device SofScale (#K903163). Bench tests included:

- Softening of simulated dental calculus via Microindentation Hardness of Materials testing (ASTM E384-22)
- pH - ISO 11609:2017
- Viscosity ISO 3219-2:2021 ー

The legally marketed primary predicate device, SofScale (#K903163) shows that it is biocompatible and safe for the intended use. Additionally, the primary predicate device, SofScale (#K903163), has been on the market for many years with a long history of safe clinical use. Since the chemical composition of EDS Calculus Softener (TURBO-CR™) is based on substantially equivalent components, the biocompatibility testing data provides further evidence of biocompatibility and overall safety. The results of the biocompatibility testing shows that the EDS Calculus Softener (TURBO-CR™) is safe for the intended use and does not elicit any adverse reactions while exhibiting excellent tolerance by the muscosal tissue (See 016_Section 15 - Biocompatibility).

## Safety:

Equivalence in safety to the predicate device is demonstrated by the results of biocompatibility tests performed according to ISO 10993, as follows:

| • 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 / (R)2014 | - | Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity. |

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Image /page/12/Picture/0 description: The image shows the logo for Essential Dental Systems. The logo is in blue and features the letters "EDS" in a stylized font. The words "ESSENTIAL DENTAL SYSTEMS" are to the right of the letters. Below the logo is the text "Essential Dental Systems, inc."

89 Leuning Street, South Hackensack, NJ 07606

- 트 ISO 10993-10:2010 / Biological Evaluation of Medical Devices - Part 10: Tests For Irritation -(R)2014 and Skin Sensitization.
- ISO 14971:2019 + Medical Devices - Application for risk management to medical devices. -A11:2021

### Performance:

Testing of physical properties according to the following standards was conducted:

| ▪ | ASTM E384-22 | - Standard Test Method for Microindentation Hardness of<br>Materials |
|---|-------------------------------------------------|-------------------------------------------------------------------------------------|
| ▪ | ISO 11609:2017 and<br>ANSI/ADA Standard No. 130 | - Dentistry - Dentifrices - Requirements, test methods and<br>marking. |
| ▪ | ISO 3219-2:2021 | - Rheology - Part 2: General principles of rotational and<br>oscillatory rheometry. |

#### 5.10. Discussion of Clinical Tests Performed: [807.92 (b)(2)]

Not Applicable.

There was no clinical testing required to support the subject medical device, EDS Calculus Softener (TURBO-CR™), as the indications for use are equivalent to the primary predicate device, SofScale (K903163). These types of devices, including the primary predicate device, have been on the market for many years with a proven clinical safety and efficacy for the intended use. A search of the FDA MAUDE database yielded no adverse events for the cited predicate device, SofScale (K903163). The verification and validation testing of the device was found to be acceptable and supports the claims of substantial equivalence.

#### 5.11. Statement of Substantial Equivalence: [807.92 (b)(3)]

The EDS Calculus Softener (TURBO-CR™) is substantially equivalent in terms of performance, indications for use, instructions for use, chemical mode of action, and biocompatibility to the cleared and marketed predicate devices, SofScale (K903163) (primary predicate device) and Therasol Tartar Dissolver (510k exempt). * Any technological differences between the EDS Calculus Softener (TURBO-CR™) and the cited predicate devices do not raise any questions regarding the safety and effectiveness of the subject device.

The information provided in this submission supports the substantial equivalence to the predicate device(s) and that the subject device is safe and effective for the users/operators.