(405 days)
510k Exempt
No
The device description focuses on the chemical and mechanical properties of the softening agent and its delivery system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is intended to facilitate the easier removal of dental calculus, tartar, and/or plaque, which are etiological factors implicated in fostering periodontal disease. By softening these substances, it aids in the cleaning and debridement process, thereby contributing to the treatment and prevention of oral health conditions.
No
Explanation: The device description states its purpose as softening dental calculus, tartar, and plaque to facilitate easier removal and reduce scaling time. It helps remove etiological factors implicated in periodontal disease. There is no mention of the device identifying, detecting, or measuring a disease or condition. It is a therapeutic/cleaning aid, not a diagnostic tool.
No
The device description clearly states it is a "professional use only product" consisting of "two component pastes that are combined in a dual barrel syringe" and dispensed using a "manual cartridge gun". This describes a physical product (pastes, syringe, gun) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EDS Calculus Softener (TURBO-CR™) is applied directly to the teeth and surrounding areas within the patient's mouth. Its purpose is to soften calculus, tartar, and plaque to facilitate their removal during a dental procedure. It does not analyze a sample taken from the body to provide diagnostic information.
- Intended Use: The intended use is to aid in the physical removal of substances from the teeth, not to diagnose a condition based on a biological sample.
- Device Description: The description details a topical application and a physical process of softening and removal, not a laboratory test or analysis of a biological sample.
- Performance Studies: The performance studies described are bench tests evaluating the physical properties of the product (softening, pH, viscosity), not clinical studies evaluating the diagnostic accuracy of a test on biological samples.
Therefore, the EDS Calculus Softener (TURBO-CR™) is a dental device used for a therapeutic/procedural purpose, not an in vitro diagnostic device.
N/A
# Intended Use / Indications for Use
Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.
# Product codes (comma separated list FDA assigned to the subject device)
ELC
# Device Description
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.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
dental arch, subgingival root surfaces, supragingival areas of teeth
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
professional use only product to be used by a dental hygienist
# Description of the training set, sample size, data source, and annotation protocol
Not Found
# Description of the test set, sample size, data source, and annotation protocol
Not Found
# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K903163](https://510k.innolitics.com/search/K903163)
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
510k Exempt
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
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.(b)
Classification. Class II.
0
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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)]
| 5.1. Application Information: | [807.92 (a)(1)] | ||
|---|---|---|---|
| Date Prepared: | May 11, 2023 | ||
| Company Name and Address: | Essential Dental Systems, inc. | ||
| 89 Leuning Street, South Hackensack, NJ 07606 | |||
| Contact: | Mr. Jason Guzman | OR | Ms. Shamal Kadam |
| Designation: | R&D Manager | Regulatory Affairs Specialist | |
| Email: | jguzman@edsdental.com | skadam@edsdental.com | |
| Phone #: | 201-487-9090 ext.119 | 201-487-9090 ext.114 | |
| Fax #: | 201-487-5120 | 201-487-5120 | |
| List of devices for which | |||
| clearance is requested: | A scaler/periodontal debriding gel called EDS Calculus Softener | ||
| (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 | ||
| (TURBO-CRTM) | SofScale | Therasol Tartar Dissolver | |
| 510(k) | |||
| Number | K223340 (under review) | K903163 | 510k Exempt |
| Manufacturer | Essential Dental Systems | Dentsply | OraTec |
| Indications for | |||
| Use | Softens dental calculus / tartar | ||
| / plaque to facilitate easier | |||
| removal; | |||
| Reduces scaling time; | |||
| May be used in hand and | |||
| ultrasonic scaling procedures | Softens calculus to facilitate | ||
| easier removal; | |||
| Reduces scaling time; | |||
| May be used in hand and | |||
| ultrasonic scaling | |||
| procedures | indicated to aid in the | ||
| removal or debridment of | |||
| dental calculus, plaque or | |||
| tartar. | |||
| Proposed Device | Primary Predicate Device | Reference Predicate Device | |
| Composition | Paste/Gel 1 - Water, Glycerol, | ||
| Polyethylene Glycol (MW | |||
| 600), Sodium Dodecyl Sulfate, | |||
| Xanthan Gum, Hydrated | |||
| Silica, Sodium Saccharin, | |||
| Sodium Dihydrogen | |||
| Phosphate, Phosphoric Acid, | |||
| Sodium Acid Pyrophosphate, | |||
| FD&C Blue 1. | |||
| Paste/Gel 2 - Water, Glycerol, | |||
| Polyethylene Glycol (MW | |||
| 600), Sodium Dodecyl Sulfate, | |||
| Peppermint Oil, Xanthan | |||
| Gum, Hydrated Silica, Sodium | |||
| Bicarbonate, Sodium | |||
| Saccharine, Tetrasodium | |||
| Pyrophosphate FD&C Yellow |
-
| Paste/Gel Water,
Denatured Ethyl Alcohol,
Hydroxyethylcellulose,
Sodium
Ethylenediaminetetraacetic
Acid (EDTA), Polysorbate
80, Sodium Lauryl Sulfate,
Sodium Bicarbonate,
Flavor, Aspartame, FD&C
Green #3. | Water, Tetrapotassium
Pyrophosphate, Sodium
Tripolyphosphate, Sodium
Bicarbonate, Citric Acid And
Sodium Fluoride. |
| Color | Paste 1 Yellow,
Paste 2 Blue,
Green upon mixing. | Green | Colorless |
| Patient
Contacting
Material(s) | Gel/Paste 1 - Water, Glycerol,
Polyethylene Glycol (MW
600), Sodium Dodecyl Sulfate,
Xanthan Gum, Hydrated
Silica, Sodium Saccharin,
Sodium Dihydrogen
Phosphate, Phosphoric Acid,
Sodium Acid Pyrophosphate,
FD&C Blue 1.
Gel/Paste 2 - Water, Glycerol,
Polyethylene Glycol (MW
| Water, Denatured Ethyl
Alcohol,
Hydroxyethylcellulose,
Sodium
Ethylenediaminetetraacetic
Acid (EDTA), Polysorbate
80, Sodium Lauryl Sulfate,
Sodium Bicarbonate,
Flavor, Aspartame, FD&C
Green #3. | Water, Tetrapotassium
Pyrophosphate, Sodium
Tripolyphosphate, Sodium
Bicarbonate, Citric Acid And
Sodium Fluoride. |
| | Proposed Device | Primary Predicate Device | Reference Predicate Device |
| | 600), Sodium Dodecyl Sulfate,
Peppermint Oil, Xantham
Gum, Hydrated Silica, Sodium
Bicarbonate, Sodium
Saccharine, Tetrasodium
Pyrophosphate FD&C Yellow
5. | | |
| Device
Description | EDS Calculus Softener
(TURBO-CRTM) is a
professional use only product
to be used by a dental
hygienist to aid in the
cleaning and removal of
dental plaque and
mineralized calculus or tartar.
The device contains chelating
agents and detergents which
reduce the hardness of or
soften mineralized plaque,
calculus, and/or tartar. | Dentsply SofScale is a
professional use only
product to be used by a
dental hygienist to aid in
the cleaning and removal
of dental plaque and
mineralized calculus or
tartar. The device contains
chelating agents and
detergents which reduce
the hardness of or soften
mineralized plaque,
calculus, and/or tartar. | Therasol Tartar Dissolver is
an over the counter use
product that is designed to
loosen, soften, or partially
dissolve dental calculus,
plaque and/or tartar
between dental visits. The
device contains chelating
agents and sodium
bicarbonate which reduce
the hardness of or soften
mineralized plaque,
calculus, and/or tartar. |
| Picture of
Device | Image: TURBO-CR product | Image: SofScale product | Image: TheraSol Tartar Dissolver product |
| Intended Use | Softens calculus, tartar, or
plaque to facilitate easier
removal; Reduces scaling
time; May be used in hand
and ultrasonic scaling
procedures. | Softens calculus, tartar, or
plaque to facilitate easier
removal; Reduces scaling
time; May be used in hand
and ultrasonic scaling
procedures. | Softens calculus, tartar, or
plaque to facilitate easier
removal; Reduces scaling
time in between office
visits; May be used in hand
and ultrasonic scaling
procedures. |
| | Proposed Device | Primary Predicate Device | Reference Predicate Device |
| Technology
Comparison | The dual gel/paste
composition contains
chelating agents, detergents,
mild abrasives, sodium
bicarbonate, gelling agents,
and flavoring that are mixed
upon delivery into a dental
tray via a double barrel
syringe. Upon mixing of the
two pastes, the material
forms a penetrating foam that
is driven into the "hard to
reach" interproximal areas
between teeth and
subgingivally to aid in the
removal of dental calculus,
tartar, and/or plaque. The
material is allowed to contact
the gumline for 1 minute
before rinsing and scaling by
the dental hygienist. | The single gel/paste
composition contains
chelating agents,
detergents, sodium
bicarbonate, gelling agents,
flavoring, and an organic
solvent (ethyl alcohol) that
is delivered via a single
barrel syringe directly to
the gum line. The material
is allowed to contact the
gumline for 1 minute
before scaling by the
dental hygienist. | The composition, a powder
containing chelating agents,
sodium bicarbonate, and
sodium fluoride, is mixed
with water before rinsing
for 1 minute in order to
soften dental calculus,
plaque, and/or plaque.
Brushing is then performed
in order to remove the
softened dental calculus,
tartar, and/or plaque. This
process is performed daily
in order to reduce dental
calculus, tartar , and/or
plaque in between dental
visits. |
| Differences* | The EDS Calculus Softener
(TURBO-CR™) is a two
component gel/paste
composition that effervesces
/foams upon mixing which
allows for penetration of the
material into the hard to
reach areas. A color change
when the two pastes are
combined ensure proper
mixing of the two
components. This device is for
professional use only. | SofScale is a single
gel/paste composition
delivered in a single barrel
syringe. This device is for
professional use only. This
device does not contain
fluoride. | Therasol Tartar Dissolver is
a powder composition that
is mixed with water before
rinsing. This composition is
an over the counter device. |
Table 5.3 - Comparison of Characteristics
7
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
8
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
9
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
10
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 (