(184 days)
Not Found
No
The summary describes a bioceramic root canal sealer and its physical properties and performance in bench and biocompatibility testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is used for permanent obturation (filling and sealing) of the root canal, which is a therapeutic intervention to treat and prevent further issues in the tooth.
No
The device is a sealer used for permanent obturation of the root canal, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "ready-to-use injectable bioceramic cement paste" packaged in a syringe with disposable tips, indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the permanent obturation (filling and sealing) of the root canal. This is a procedure performed within the patient's body to treat a dental issue.
- Device Description: The device is a cement paste used for filling the root canal. It is applied directly to the anatomical site.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a medical device used for a therapeutic procedure within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
- Permanent obturation of the root canal following vital pulp-extirpation.
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
- Suitable for use in single cone and lateral condensation technique.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
EDS Bioceramic sealer (Bioseal) is a ready-to-use injectable bioceramic cement paste developed for permanent root canal filling and sealing applications. EDS Bioceramic Sealer (Bioseal) is an insoluble, radiopaque material based on a calcium silicate and calcium phosphate composition, which requires the presence of water to set and harden. EDS Bioceramic Sealer (Bioseal) does not shrink during setting. EDS Bioceramic Sealer (Bioseal) is packaged in a pre-loaded syringe and is supplied with disposable Intra Canal Tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare professionals.
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)
The EDS Bioceramic Sealer (Bioseal) has undergone extensive bench (ISO 6876:2012) and biocompatibility testing to provide evidence that the physical and chemical properties of the composition are substantially equivalent to EndoSequence BC Sealer (K120048). Bench tests included: Flow, Setting time, Solubility, Radiopacity, Film thickness.
Equivalence in safety to the predicate device is demonstrated by the results of six biocompatibility tests performed according to ISO 10993, as follows:
- ISO 14971:2007 - Medical Devices - Application for risk management to medical devices
- ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-3:2014 - Biological Evaluation of Medical Devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity and implantation
- ISO 10093-6:2016 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- ISO 10993-10:2010 - Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- ISO 10993-11:2017 - Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
The results of the biocompatibility testing shows that the EDS Bioceramic Sealer (Bioseal) is non-mutagenic, noncytotoxic and does not elicit an allergenic response while exhibiting excellent tolerance by the subcutaneous tissue.
Testing of physical properties according to the following standards have demonstrated equivalence in performance to the predicate device:
- ISO 6876:2012 - Dentistry – Root Canal Sealing Materials
- ISO 7405:2018 - Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
- ANSI / ADA Specification No. 57 - Endodontic Sealing Materials
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.
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.
Not Found
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
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
February 12, 2021
Essential Dental Systems Jason Guzman R&D Manager 89 Leuning Street South Hackensack, New Jersey 07606
Re: K202281
Trade/Device Name: EDS Bioceramic Sealer (Bioseal) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: December 21, 2020 Received: December 22, 2020
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 (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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
Indications for Use
510(k) Number (if known) K202281
Device Name EDS Bioceramic Sealer (Bioseal)
Indications for Use (Describe)
-
Permanent obturation of the root canal following vital pulp-extirpation.
-
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
-
Suitable for use in single cone and lateral condensation technique.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5 - 510(k) Summary
[21 CFR 807.92 (c)]
| 1. | Application Information: [807.92 (a)(1)] | ||
|---|---|---|---|
| Date Prepared: July 6, 2020 | |||
| Company Name and Address: | Essential Dental Systems | ||
| 89 Leuning Street, South Hackensack, NJ 07606 | |||
| Contact: | Mr. Jason Guzman | 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: | Root canal sealing material called EDS Bioceramic Sealer (Bioseal) |
2. Name of the Device: [807.92 (a)(2)]
| Trade name: | EDS Bioceramic Sealer (Bioseal) |
|---|---|
| Device Type: | Resin, Root Canal Filling |
| Regulation Description: | Root Canal Filling Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3820 |
| Device class: | Class II |
| Product Code: | KIF |
3. Predicate Device Information: [807.92 (a)(3)]
The legally marketed devices to which substantial equivalence is being claimed are:
Table 5A - Predicate Devices
| Device | Manufacturer | 510K number | |
|---|---|---|---|
| 1. | EndoSequence BC Sealer | Brasseler | K120048 |
| 2. | ProSmart Root Canal Obturation System | DRFP | K100248 |
4. Device Description: [807.92 (a)(4)]
EDS Bioceramic sealer (Bioseal) is a ready-to-use injectable bioceramic cement paste developed for permanent root canal filling and sealing applications. EDS Bioceramic Sealer (Bioseal) is an insoluble, radiopaque material based on a calcium silicate and calcium phosphate composition, which requires the presence of water to set and harden. EDS Bioceramic Sealer (Bioseal) does
4
not shrink during setting. EDS Bioceramic Sealer (Bioseal) is packaged in a pre-loaded syringe and is supplied with disposable Intra Canal Tips.
5. Device Configuration: [807.92 (a)(4)]
lt consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. It is used in combination with gutta-percha points during root canal obturation. It is packaged in the familiar double-barrel syringe configuration used by numerous other dental materials. The steps required to properly express the cement are: remove cap, attach mixer, attach dispensing top, press plunger. After use, the mixer / dispensing tip should be discarded and the cap replaced. The device is provided non-sterile.
6. Device Composition:
- -Calcium Silicates
- -Zirconium Oxide
- -Calcium Hydroxide
- -Halloysite clay
- -Polyacrylic acid
- -Bioactive Glass (45S5)
- -Calcium Phosphate Monobasic
- β-Tricalcium Phosphate
- -Silica thickening Agents
- Chlorhexidine -
- -Polyethylene glycol (MW 300)
7. Intended Use: [807.92 (a)(5)]
The EDS Bioceramic Sealer (Bioseal) is indicated for permanent sealing of root canals following established endodontic procedures. Permanent obturation of the root canal following vital pulpextirpation or removal of infected or necrotic pulp followed by the placement of intra-canal dressings. The EDS Bioceramic Sealer (Bioseal) is suitable for use in single cone and lateral condensation technique.
8. Indications for Use: [807.92 (a)(5)]
- l Permanent obturation of the root canal following vital pulp-extirpation.
- . Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
- l Suitable for use in single cone and lateral condensation technique.
5
9. Substantial Equivalence Discussion: [807.92 (a)(6)]
A comparison of EDS Bioceramic Sealer (Bioseal) 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 Bioceramic Sealer
(Bioseal) | EndoSequence BC Sealer | ProSmart Root Canal
Obturation System |
| 510(k)
Number | K202281 | K120048 | K100248 |
| Manufacturer | Essential Dental Systems | Brasseler | DRFP |
| Indications for
Use | Permanent obturation
of the root canal
following vital pulp-
extirpation.
Permanent obturation
of the root canal
following removal of
infected or necrotic
pulp and placement of
intracanal dressings.
Suitable for use in
single cone and lateral
condensation
technique. | Permanent obturation
of the root canal
following vital pulp-
extirpation.
Permanent obturation
of the root canal
following removal of
infected or necrotic
pulp and placement of
intracanal dressings.
Suitable for use in
single cone and lateral
condensation
technique. | Permanent obturation
of the root canal
following vital pulp-
extirpation.
Permanent obturation
of the root canal
following removal of
infected or necrotic
pulp and placement of
intracanal dressings.
Suitable for use in
single cone and lateral
condensation
technique. |
| Composition | Calcium Silicates, Calcium
Phosphate monobasic, β-
Tricalcium Phosphate,
Zirconium Oxide,
Polyethylene glycol (MW
300), Calcium Hydroxide,
silica thickening agents.
Bioactive Glass (45S5),
Polyacrylic acid,
Chlorhexidine, Halloysite
clay. | Calcium Silicates, Calcium
Phosphates, Zirconium
Oxide, Polyethylene glycol,
Calcium Hydroxide, Filler
and Silica Thickening
Agents. | Epoxy-Amine Resin,
Hydrophilic Polymers,
Calcium Hydroxide, Metal
Oxides, Filler and
Thickening Agents. |
6
Image /page/6/Picture/0 description: The image is a logo for Essential Dental Systems. The logo is in blue and white and features the letters "EDS" in a stylized font. To the right of the letters is the text "ESSENTIAL DENTAL SYSTEMS" in a smaller font. The logo is enclosed in a rounded rectangle.
Essential Dental Systems, Inc.
Essential Dental Systems, inc.
Essential Dental Systems, inc. 89 Leuning Street, South Hackensack, NJ 07606
Submission Number: K202281 EDS Bioceramic Sealer (Bioseal) Traditional 510(k) - Original
| | Proposed Device | Primary Predicate Device | Reference Predicate
Device |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shades | White | White | White |
| Tissue
Contacting
Device
Material(s) | Calcium Silicates, Calcium
Phosphate monobasic, β-
Tricalcium Phosphate,
Zirconium Oxide,
Polyethylene glycol (MW
300), Calcium Hydroxide,
Silica thickening agents.
Bioactive Glass (45S5),
Polyacrylic acid,
Chlorhexidine, Halloysite
clay. | Zirconium Oxide, Calcium
Phosphates, Tricalcium
Silicate, Dicalcium Silicate,
Calcium Hydroxide,
Polyethylene glycol, Silica
Filler, and Silica Thickening
Agents. | Calcium Phosphate, Epoxy
- Amine Resin, Silica Filler,
and Thickening Agents. |
| Device
Description | EDS Bioceramic sealer
(Bioseal) is a ready-to-use
injectable bioceramic
cement paste developed
for permanent root canal
filling and sealing
applications. EDS
Bioceramic Sealer
(Bioseal) is an insoluble,
radiopaque material
based on a calcium
silicate and calcium
phosphate composition,
which requires the
presence of water to set
and harden. EDS
Bioceramic Sealer
(Bioseal) does not shrink
during setting. EDS
Bioceramic Sealer
(Bioseal) is packaged in a
pre-loaded syringe and is
supplied with disposable
Intra Canal Tips. | Premixed ready-to-use
injectable white hydraulic
cement paste developed
for permanent root canal
filling and sealing
applications. It is based on
a primarily calcium
silicate/calcium phosphate
composition and requires
the presence of water to
set and harden. Supplied
in a single barrel syringe. | The ProSmart uses
hydrophylic polymers
which allows the material
to expand into
irregularities and tubules
of the root canal to assure
a tight mechanical seal
with the dentin. |
7
Image /page/7/Picture/0 description: The image is a logo for Essential Dental Systems (EDS). The logo is in blue and consists of the letters "EDS" in a stylized font, with the words "ESSENTIAL DENTAL SYSTEMS" to the right of the letters. The logo is enclosed in a rounded rectangle.
C Essential Denta Essential Dental Systems, inc. 89 Leuning Street, South Hackensack, NJ 07606
Submission Number: K202281 EDS Bioceramic Sealer (Bioseal) Traditional 510(k) - Original
| | Proposed Device | Primary Predicate Device | Reference Predicate
Device |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Picture of
Device | Image: Proposed Device | Image: Primary Predicate Device | Image: Reference Predicate Device |
| Intended Use | Endsequence BC Sealer is
intended for permanent
sealing of root canals
following established
endodontic procedures
by qualified healthcare
professionals. | Endsequence BC Sealer is
intended for permanent
sealing of root canals
following established
endodontic procedures by
qualified healthcare
professionals. | The ProSmart is designed
for the permanent sealing
of root canals following
established endodontic
procedures by qualified
healthcare professionals. |
| Technology
Comparison | EDS Bioceramic Sealer
(Bioseal) uses a dual
syringe system to ensure
an equal 1:1 mixing of the
two hydraulic paste
composition. The
composition contains
absorbant halloysite clays
in order to ensure
hydration / efficient
setting of the cement.
The subject device,
contains further agents
that serve as additional
ion sources. These
include bioactive glass
(45S5) as well as different
forms of calcium
phosphates (monobasic
calcium phosphate, β Tri-
calcium phosphate). As
these ion rich
components become
hydrated in the root
canal, they further | The EndoSequence comes
Pre-mixed and ready-to-
use injectable white
hydraulic cement paste in
a single barrel syringe. The
EndoSequence bioceramic
sealer is based on a
calcium silicate / calcium
phosphate composition
and requires water to set
and harden. | The DRFP ProSmart comes
with its two - component
catalyst paste based on
epoxy-amine resin
chemistry. The paste
additionally comes with an
"active powder" that must
be mixed to provide the
paste with its hydrophilic
properties to allow the
mixture to expand into
crevices and dentine
tubules. |
8
Image /page/8/Picture/0 description: The image is a logo for Essential Dental Systems (EDS). The logo is in blue and consists of the letters "EDS" in a bold, stylized font. To the right of the letters, the words "ESSENTIAL DENTAL SYSTEMS" are stacked vertically. The logo is enclosed in a rounded rectangle with a registered trademark symbol in the upper right corner.
C Essential Dental Essential Dental Systems, inc. 89 Leuning Street, South Hackensack, NJ 07606
| Proposed Device | Primary Predicate Device | Reference Predicate Device |
|---|---|---|
| contribute to the precipitation/formation of a hard mineral phase that structurally reinforces the endodontically treated tooth over time. The addition of trace amounts of chlorhexidine and poly acrylic acid aid in the stabilization and coordination of precipitated calcium and other ions via electrostatic interactions. These stabilized / precipitated ions aid in the sealing of the root canal system. |
| Differences | The EDS Bioceramic
Sealer (Bioseal) is
supplied with a two
barrel syringe delivery
system in order to ensure
proper mixing. The
composition contains
absorbant halloysite clays
in order to ensure
hydration / efficient
setting of the cement.
The subject device,
contains further agents
that serve as additional
ion sources. These
include bioactive glass
(45S5) as well as different
forms of calcium | Delivered in a single barrel
syringe delivery system. | Two-component catalyst
paste based on epoxy-
amine resin chemistry. The
paste additionally comes
with an "active powder"
that must be mixed by
hand and applied. |
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
9
Image /page/9/Picture/0 description: The image is a logo for Essential Dental Systems. The logo is in blue and consists of the letters "EDS" in a stylized font, with the words "ESSENTIAL DENTAL SYSTEMS" to the right of the letters. The logo is enclosed in a rounded rectangle. There is a registered trademark symbol in the upper right corner of the rectangle.
Essential D Essential Dental Systems, inc. 89 Leuning Street, South Hackensack, NJ 07606
| phosphates (monobasic
calcium phosphate, β Tri-
calcium phosphate). As
these ion rich
components become
hydrated in the root
canal, they further
contribute to the
precipitation/formation
of a hard mineral phase
that structurally
reinforces the
endodontically treated
tooth over time. The
addition of trace amounts
of chlorhexidine and poly
acrylic acid aid in the
stabilization and
coordination of
precipitated calcium and
other ions via
electrostatic interactions.
These
stabilized/precipitated
ions aid in the sealing of
| the root canal system. | |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
10
Similarities and Differences:
The EDS Bioceramic Sealer (Bioseal) is similar to the predicate devices EndoSequence BC Sealer (K120048) and ProSmart Root Canal Obturation System (K100248). These are available as radiopaque pastes essentially designed for equivalent dental applications and have comparable physical properties, performance specifications and share specific chemical components. The principal composition of the EDS Bioceramic Sealer (Bioseal) is based on EndoSequence BC Sealer (K120048). Both the aforementioned predicate devices contain specific chemical components that are identical or equivalent to those found in the EDS Bioceramic Sealer (Bioseal). The subject device, however, contains further agents that serve as additional ion sources that contribute to the sealing of the root canal. These include bioactive glass (4555) as well as different forms of calcium phosphates (monobasic calcium phosphate, β Tri-calcium phosphate). As these ion rich components become hydrated in the root canal, they further contribute to the precipitation/formation of a hard mineral phase that structurally reinforces the endodontically treated tooth over time. The addition of trace amounts of chlorhexidine and poly acrylic acid aid in the stabilization and coordination of precipitated calcium and other ions via electrostatic interactions. While these are some of the differences between the subject device and predicate device EndoSequence BC Sealer (K120048), the vast majority of the both compositions are primarily composed of calcium silicates, zirconium oxide, and low molecular weight polyethylene glycol which accounts for well over 90% of the composition. Both compositions, the subject and predicate devices, utilize polyethylene glycol as a nonaqueous liquid carrier where all of the other components are suspended to yield a flowable-injectable paste. Both devices have identical indications for use as root canal sealers. While the subject device has some additional additives, the technological characteristics, mode and mechanism of action for both devices, subject device and predicate device, are identical. All of the components found in the predicate devices have been used in legally marketed devices and were for dental use. 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 Bioceramic Sealer (Bioseal) for the indicated uses.
10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: [807.92 (b)(1)]
The EDS Bioceramic Sealer (Bioseal) has undergone extensive bench (ISO 6876:2012) and biocompatibility testing to provide evidence that the physical and chemical properties of the composition are substantially equivalent to EndoSequence BC Sealer (K120048). Bench tests included:
- | Flow
- Setting time -
- -Solubility
- -Radiopacity
- Film thickness -
11
The legally marketed and extensively tested EndoSequence BC Sealer (K120048) shows that it is exceptionally biocompatible and safe for the intended use. Since the chemical composition of EDS Bioceramic Sealer (Bioseal) is based on EndoSequence BC Sealer (K120048), the biocompatibility test data provides further evidence of biocompatibility and over all safety. The results of the biocompatibility testing shows that the EDS Bioceramic Sealer (Bioseal) is non-mutagenic, noncytotoxic and does not elicit an allergenic response while exhibiting excellent tolerance by the subcutaneous tissue.
Testing of biocompatibility and physical properties were conducted to determine equivalence of the EDS Bioceramic Sealer (Bioseal) [K202281] to the predicate device EndoSequence BC Sealer [K120048].
Safety:
Equivalence in safety to the predicate device is demonstrated by the results of six biocompatibility tests performed according to ISO 10993, as follows:
| ▪ ISO 14971:2007 | - | Medical Devices - Application for risk management to medical devices |
|---|---|---|
| ▪ ISO 10993-1:2018 | - | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ▪ ISO 10993-3:2014 | - | Biological Evaluation of Medical Devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ▪ ISO 10993-5:2009 | - | Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity and implantation |
| ▪ ISO 10093-6:2016 | - | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation |
| ▪ ISO 10993-10:2010 | - | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization |
| ▪ ISO 10993-11:2017 | - | Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity |
Performance:
Testing of physical properties according to the following standards have demonstrated equivalence in performance to the predicate device.
| ■ ISO 6876:2012 | - | Dentistry – Root Canal Sealing Materials |
|---|---|---|
| ■ ISO 7405:2018 | - | Dentistry – Evaluation of biocompatibility of medical devices |
| used in dentistry | ||
| ■ ANSI / ADA | ||
| Specification No. 57 | - | Endodontic Sealing Materials |
12
11. Discussion of Clinical Tests Performed: [807.92 (b)(2)]
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The verification and validation testing of the device was found to be acceptable and supports the claims of substantial equivalence.
12. Conclusions: [807.92 (b)(3)]
The EDS Bioceramic Sealer (Bioseal) is substantially equivalent in terms of performance, indications for use, and biocompatibility to the cleared and marketed predicate devices EndoSequence BC Sealer (K120048) and ProSmart Root Canal Obturation System (K100248). Any technological differences between the EDS Bioceramic Sealer (Bioseal) and the predicate device(s) 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 system is safe and effective for the users/operators.