(93 days)
No
The summary describes a traditional dental restorative material and does not mention any AI or ML components or functionalities.
Yes
The device is a restorative material used for reconstructing or correcting natural dentition, which aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
The device is described as a restorative material intended for the reconstruction or correction of natural dentition, not for diagnosing conditions.
No
The device description explicitly states that the devices are "light-cured methacrylate-based resins" and "light cured radiopaque microhybrid composites," which are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reconstruction or correction of natural dentition" and "restoration of cavities." This describes a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is described as a "restorative material," "light-cured methacrylate-based resins that are intended to fill and restore small to large defects or carious lesions in teeth." This further reinforces its role in treating or repairing teeth.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to provide information about a disease or condition.
- Anatomical Site: The anatomical site is "Natural dentition," which is the target for restoration, not for obtaining diagnostic samples.
IVD devices are specifically designed to perform tests in vitro (outside the body) on samples from the human body to provide diagnostic information. This device is used in vivo (within the body) for restorative purposes.
N/A
Intended Use / Indications for Use
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
- Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
- Indirect anterior and posterior restorations including inlays, onlays and veneers
- Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
- Splinting
els extra low shrinkage® flow is indicated for:
- Restorations with minimally invasive preparation technique
- Restorations of small cavities and extended fissure sealing
- Alternate restorations for undercut cavities
- Restorations of class III V including wedged shaped defects and cervical caries
- Repair of fillings, veneers and methacrylate-based temporary restorations
- First layer of fillings for Class I and II
- Interlocking of loosened teeth
- Adhesive attachment of indirect composite and ceramic restorations
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
els extra low shrinkage® composite is classified as a Type 1, Class 2, Group 1 & 2 Polymerbased restorative material according to ISO 4049:2009 - Dentistry - Polymer-based restorative materials.
els extra low shrinkage® flow is classified as Type 2, Class 2, Group 1 Polymer-based restorative material according to ISO 4049:2009 – Dentistry – Polymer-based restorative materials.
els extra low shrinkage® composite & els extra low shrinkage® flow are light-cured methacrylate-based resins that are intended to fill and restore small to large defects or carious lesions in teeth.
Material Composition: els extra low shrinkage® composite & els extra low shrinkage® flow are composed of methacrylate-based resins, dental glass-filler, photo initiators and pigments.
Technological Characteristics: els extra low shrinkage® composite & els extra low shrinkage® flow are light cured radiopaque microhybrid composites with extremely low shrinkage stress.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural dentition, teeth
Indicated Patient Age Range
The patient population includes with permanent dentition needing restoration.
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance Testing: els extra low shrinkage® composite & els extra low shrinkage® flow were tested and met the applicable requirements of the following ISO standard ISO 4049:2009 - Dentistry -Polymer-based restorative materials. Bench test results allowed us to conclude that els extra low shrinkage® composite & els extra low shrinkage® flow meet their intended uses.
Biocompatibility: els extra low shrinkage® composite & els extra low shrinkage® flow meet the biocompatibility requirements of the following standards:
- ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- ISO 7405:2018 Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Clinical Performance Data: The performance of methacrylate-based polymer resins in the clinical environment has been well established. No human clinical testing was performed to support the substantial equivalence of els extra low shrinkage® composite & els extra low shrinkage® flow.
Summary of Performance Studies results are in tables, refer to document for details.
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.
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 27, 2024
Saremco Dental AG % Nevine Erian Regulatory Consultant BOC Consulting, LLC 24341 Barbados Dr. Dana Point, California 92629-92629
Re: K240823
Trade/Device Name: els extra low shrinkage® composite & els extra low shrinkage® flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: March 21, 2024 Received: March 26, 2024
Dear Nevine Erian:
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.
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"
1
(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 OS 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).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
2
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
els extra low shrinkage® composite & els extra low shrinkage® flow
Indications for Use (Describe)
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
- D Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
- [ Indirect anterior and posterior restorations including inlays, onlays and veneers
- [ Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
- 0 Splinting
els extra low shrinkage® flow is indicated for:
- [ Restorations with minimally invasive preparation technique
- [ Restorations of small cavities and extended fissure sealing
- [ Alternate restorations for undercut cavities
- [ Restorations of class III V including wedged shaped defects and cervical caries
- □ Repair of fillings, veneers and methacrylate-based temporary restorations
- □ First layer of fillings for Class I and II
- I Interlocking of loosened teeth
- [ Adhesive attachment of indirect composite and ceramic restorations
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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4
K240823 – 510(k) Summary
| Submitter | Saremco Dental AG
Gewerbestrasse 4
CH-9445 Rebstein, Switzerland
Establishment Reg. No. 3008582054 |
|-----------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Christoph Evers
Head of R&D
Phone +41 71 775 80 90
Fax +41 71 775 80 99
E-Mail christoph.evers@saremco.ch |
| Official Correspondent | Nevine Erian |
|---|---|
| Regulatory Consultant | |
| BQC Consulting, LLC | |
| 24341 Barbados Dr. | |
| Dana Point, CA 92629 | |
| Phone (949) 370-7155 | |
| Fax (949) 240-8829 | |
| E-mail nevine@bqcconsulting.com |
Date Prepared June 24, 2024
| Trade/Device Names | els extra low shrinkage® composite
els extra low shrinkage® flow |
|--------------------------------------------|---------------------------------------------------------------------|
| Common Name | Tooth Shade Resin Material |
| Classification Name &
Regulation Number | Tooth Shade Resin Material - 21 CFR 872.3690 |
| Product Code | EBF |
Predicate Devices
DENU Composite Resin (HDI, Inc.) – K213339 – Primary Predicate
Brilliant EverGlow Flow (Coltene/Whaledent AG) – K190597 – Reference Device
Brilliant Componeer (Coltene/Whaledent AG) – K191385 – Reference Device
Venus Diamond flow (Heraeus Kulzer GmbH) – K091635 – Reference Device
5
Device Description
els extra low shrinkage® composite is classified as a Type 1, Class 2, Group 1 & 2 Polymerbased restorative material according to ISO 4049:2009 - Dentistry - Polymer-based restorative materials.
els extra low shrinkage® flow is classified as Type 2, Class 2, Group 1 Polymer-based restorative material according to ISO 4049:2009 – Dentistry – Polymer-based restorative materials.
Statement of Intended Use
els extra low shrinkage® composite & els extra low shrinkage® flow are light-cured methacrylate-based resins that are intended to fill and restore small to large defects or carious lesions in teeth. The patient population includes with permanent dentition needing restoration.
Statement of Indication for Use
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
- Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
- . Indirect anterior and posterior restorations including inlays, onlays and veneers
- Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
- 트 Splinting
els extra low shrinkage® flow is indicated for:
- 트 Restorations with minimally invasive preparation technique
- 트 Restorations of small cavities and extended fissure sealing
- 트 Alternate restorations for undercut cavities
- . Restorations of class III - V including wedged shaped defects and cervical caries
- 트 Repair of fillings, veneers and methacrylate-based temporary restorations
- 트 First layer of fillings for Class I and II
- 트 Interlocking of loosened teeth
- Adhesive attachment of indirect composite and ceramic restorations
Material Composition
els extra low shrinkage® composite & els extra low shrinkage® flow are composed of methacrylate-based resins, dental glass-filler, photo initiators and pigments.
Technological Characteristics
els extra low shrinkage® composite & els extra low shrinkage® flow are light cured radiopaque microhybrid composites with extremely low shrinkage stress.
6
Non-Clinical Performance Testing
els extra low shrinkage® composite & els extra low shrinkage® flow were tested and met the applicable requirements of the following ISO standard ISO 4049:2009 - Dentistry -Polymer-based restorative materials
Bench test results allowed us to conclude that els extra low shrinkage® composite & els extra low shrinkage® flow meet their intended uses.
Biocompatibility
els extra low shrinkage® composite & els extra low shrinkage® flow meet the biocompatibility requirements of the following standards:
- l ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- -ISO 7405:2018 Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Clinical Performance Data
The performance of methacrylate-based polymer resins in the clinical environment has been well established. No human clinical testing was performed to support the substantial equivalence of els extra low shrinkage® composite & els extra low shrinkage® flow.
Substantial Equivalence
The technical characteristics of els extra low shrinkage® composite & els extra low shrinkage® flow are substantially equivalent to the predicate devices.
Material
els extra low shrinkage® composite & els extra low shrinkage® flow are resin-based materials as the predicate devices.
Physical Properties
els extra low shrinkage® composite & els extra low shrinkage® flow have similar physical properties as the predicate devices.
Comparison of saremco els extra low shrinkage® composite (els composite for short) to Predicate Devices
7
8
| Attribute | els composite | DENU Composite
Resin | Brilliant
Componeer | Rationale for Difference |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | els extra low
shrinkage®
composite is a
restorative
material intended
for the
reconstruction or
correction of
natural dentition.
- Restoration of
class I, II, III, IV
and V cavities on
anterior and
posterior teeth - Indirect anterior
and posterior
restorations
including inlays,
onlays and
veneers - Aesthetic
corrections of
interdental
spaces, enamel
hypoplasia,
discolorations - Splinting | DENU Composite
Resin is indicated
for use in: - Direct anterior
and posterior
restorations - Core buildup
- Splinting
- Indirect anterior
and posterior
restorations
including inlays,
onlays and
veneers | Clinical indications - Restoration of
caries defects - Reconstruction
of lost tooth
substance due to
attrition,
abrasion, erosion - Restoration of
tooth fractures - Correction of
anatomical
malformation
Cosmetic
indications - Optimisation of
old composite
restorations - Extending
incisors - Correction of
malpositioned
teeth - Cosmetic
corrections for
tooth
discolouration or
incorrect shading - Closure of
diastema | The verbiage describing the indications
for Use of els composite and the
predicate, DENU Composite resin, is
slightly different. The wording used by
the primary predicate (namely: "Direct
anterior and posterior restorations")
describes a much broader field in
comparison to "Restoration of class I, II,
III, IV and V cavities on anterior and
posterior teeth". The indications
"Indirect anterior and posterior
restorations including inlays, onlays and
veneers" and "Splinting" are equal on
both sides.
The formulations describing the
indications for the use of els composite
and the predicate "Brilliant Componeer"
are different. The wording of the
predicate (namely: " - Restoration of caries defects
- Reconstruction of lost tooth substance
due to attrition, abrasion, erosion - Restoration of tooth fractures
- Correction of anatomical
malformation") also describes a much
broader range compared to the
indications of the els composite
"Restoration of class I, II, III, IV and V
cavities on anterior and posterior
teeth", "Indirect anterior and posterior
restorations including inlays, onlays and
veneers" and "Splinting".
The other indications of the predicate
device "Brilliant Componeer" in
comparison to the proposed els
composite hybrid list the esthetic
corrections: (Cosmetic indications - Optimization of old composite
restorations - Extending incisors
- Correction of mal-positioned teeth
- Cosmetic corrections for tooth
discoloration or incorrect shading - Closure of diastema"),
whereby a much broader range of
esthetic corrections is also mentioned |
| Attribute | els composite | DENU Composite
Resin | Brilliant
Componeer | Rationale for
Difference |
| Physical Properties | | | | |
| Physical State | Uncured resin
paste | Uncured resin
paste | Polymerized
prefabricated
hybrid composite
enamel shell | After light curing,
els composite and
Denu Composite
Resin perform the
same as Brilliant
Componeer |
| Material Color | Various shades | Various shades | Various shades | Shade differences
do not affect device
performance |
| Packaging | Prefilled syringes
& tips | Prefilled syringes | Preformed shells
in box | Packaging
differences do not
impact cured
device performance |
| Compressive
Strength | Avg. = 289.8 MPa | 187.4 MPa | 285 MPa | Though different
compressive
strength values, in
subject and
predicate devices,
higher strength of
els composite does
not affect
substantial
equivalence. |
| Surface Hardness | Avg. = 76
Vicker's Hardness | 43.86 KHN | Unknown | Surface hardness
values are not
comparable due to
lack of available
data. Vicker's
Hardness is a
typical standard for
composites. |
| Performance Testing | ISO 4049 | ISO 4049 | ISO 4049 | |
| Flexural Strength | Avg. = 116.3 MPa | 135.74 MPa | 125.4 MPa | Though different
values, subject and
predicate devices
meet same ISO
4049 performance
requirements |
| Attribute | els composite | DENU Composite
Resin | Brilliant
Componeer | Rationale for
Difference |
| Water Sorption | Avg. =14.7 µg/mm3 | 18.48 µg/mm3 | 18.2 µg/mm3 | Though different
values, subject and
predicate devices
meet same ISO
4049 performance
requirements |
| Solubility | Avg. = 0.8 µg/mm3 | 0.82 µg/mm3 | 0.3 µg/mm3 | Though different
values, subject and
predicate devices
meet same ISO
4049 performance
requirements |
| Depth of Cure | ≥ 1.5 mm | ≥ 1.5 mm | ≥ 1.5 mm | - |
| Radiopacity | Avg. = 2.8 mm Al | 3.2 mm Al | 3.2 mm Al | Though different
values, subject and
predicate devices
meet same ISO
4049 performance
requirements |
| Material
Comparison | | | | |
| Chemical
Characterization | Methacrylate-based
resins, dental glass-
filler, photo
initiators
and pigments. | Methacrylate-
based resins,
dental glass-filler,
photo initiators
and pigments. | Methacrylate-
based resins,
dental glass-filler,
photo initiators
and pigments. | |
| Technical Attributes | | | | |
| Product Code(s) | EBF | EBF, EBC & EJK | EBF | Subject device has
less indications
than predicates |
| Fabrication Method | Light Cured | Light Cured | Light Cured | After light curing,
els composite and
Denu Composite
Resin perform the
same as Brilliant
Componeer |
| Curing Wavelength | 400 - 500 nm | 400 - 500 nm | Unknown | - |
| Polymerization
Method | UV Curing Light | UV Curing Light | UV Curing Light | - |
| Sterile | No | No | No | - |
| Rx or OTC | Rx | Rx | Rx | - |
| Attribute | Els flow | BRILLIANT
EverGlow Flow | Venus Diamond flow | Rationale for Differnce |
| Indi-
cation | els extra low
shrinkage® flow is
a restorative
material intended
| BRILLIANT EverGlow
Flow Universal and
Translucent shades
are suitable for: - Direct class V
fillings (cervical
caries, root erosion,
wedge-shaped
defects) - Fillings in the
anterior tooth
region (Class III and
IV) - Small fillings of all
cavity classes (not
occlusion-bearing) - Blocking out of
undercuts - Adhesive luting of
indirect composite
and ceramic
restorations in as far
as accuracy of fit
and light
permeability are
given - Repairs of direct
and indirect
composite
restorations - Preventive resin
restorations - Cavity lining
BRILLIANT EverGlow
Flow opaque shade
is also suitable for: - Aesthetic
corrections (e.g.
deviations in
chroma) - Masking of dark
areas | - Enlarged fissure
sealing - Cavity lining - as the
first layer for
Class I and II cavities - Class V fillings
- Minimally invasive
Class I and II fillings in
areas not subjected
to masticatory forces - Minimally invasive
Class III fillings - Small repairs of
direct and indirect
restorations
combined with a
suitable bonding
agent - Interlocking of
loosened teeth | The formulations describing
the indications for the use of
els-Flow and the predicate
"Brilliant Everglow flow" are
very similar. Only the
indication "blocking of
loosened teeth" is not
mentioned. Although not
explicitly mentioned, all
indications describe "fillings
with minimally invasive
preparation technique", which
also covers this indication of els
flow.
The formulations describing
the indications for the use of
els Flow and the "Venus
Diamond flow" predicate are
also very similar. However, the
indications "Replacement
fillings in cavities with
undercuts" and "Adhesive
cementation of indirect
composite or ceramic
restorations" are missing here,
but these are covered by the
"Brilliant Everglow flow"
predicate. |
| Attribute | els flow | BRILLIANT
EverGlow Flow | Venus Diamond
flow | Rationale for Difference |
| Physical
Properties | | | | |
| Physical State | Uncured resin paste | Uncured resin paste | Uncured resin paste | - |
| Material Type | Polymer resin
composite | Polymer resin
composite | Polymer resin
composite | - |
| Material Color | Various shades | Various shades | Various shades | Shade differences do not
affect device performance |
| Packaging | Prefilled syringes | Prefilled syringes | Prefilled syringes | - |
| Compressive
Strength | Avg. = 225.1 MPa | 415 MPa | 332 MPa | Though different
compressive strength
values, in subject and
predicate devices, els flow
is only used for small
cavities, which do not
require higher compressive
strength |
| Surface
Hardness | Avg. = 55
Vicker's Hardness | Unknown | Unknown | No available data to
compare with |
| Performance
Testing | ISO 4049 | ISO 4049 | ISO 4049 | - |
| Flexural
Strength | Avg. = 116.5 MPa | 96 MPa | 117 MPa | Though different values,
subject and predicate
devices meet same ISO
4049 performance
requirements |
| Water
Sorption | Avg. = 19.0 µg/mm³ | 23 µg/mm³ | ≤40 µg/mm³ | Though different values,
subject and predicate
devices meet same ISO
4049 performance
requirements |
| Solubility | Avg. = 1.5 µg/mm³ | 2.0 µg/mm³ | ≤ 7.5 µg/mm³ | Though different values,
subject and predicate
devices meet same ISO
4049 performance
requirements |
| Depth of Cure | ≥ 1.5 mm | ≥ 1.5 mm | ≥ 1.5 mm | - |
| Radiopacity | Avg. = 1.3 mm Al | 2.2 mm Al | 3.1 mm Al | Though different values,
subject and predicate
devices meet same ISO
4049 performance
requirements |
| Attribute | els flow | BRILLIANT
EverGlow Flow | Venus Diamond
flow | Rationale for Difference |
| Material
Comparison | | | | |
| Chemical
Characterizatio
n | Methacrylate-based
resins, dental glass-
filler, photo
initiators
and pigments. | Methacrylate-based
resins, dental glass-
filler, photo
initiators
and pigments. | Methacrylate-based
resins, dental glass-
filler, photo
initiators
and pigments. | |
| Technical
Attributes | | | | |
| Product
Code(s) | EBF | EBF | EBF, EBC & LBH | Subject device has less
indications than Venus
Diamond flow |
| Fabrication
Method | Light Cured | Light Cured | Light Cured | |
| Curing
Wavelength | 400 - 500 nm | 430 - 490 nm | 450 - 480 nm | Subject device curing
wavelength is comparable
to predicates |
| Polymerization
Method | UV Curing Light | UV Curing Light | UV Curing Light | |
| Sterile | No | No | No | |
| Rx or OTC | Rx | Rx | Rx | |
9
10
11
Comparison of saremco els extra low shrinkage® flow (els flow for short) to Predicate Devices
12
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Differences between els extra low shrinkage® composite & els extra low shrinkage® flow and Predicate Devices
The differences in the physical properties and chemical compositions between els extra low shrinkage® composite & els extra low shrinkage® flow and the predicate devices do not impact the substantial equivalence, as the finished clinical product is a custom-fitted biocompatible restoration regardless of the material variation.
Conclusion
Information provided in this application demonstrates that els extra low shrinkage® composite & els extra low shrinkage® flow are substantially equivalent to the predicate devices. els extra low shrinkage® composite & els extra low shrinkage® flow share the
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same indications for use, similar material composition, similar physical properties and technological characteristics as the predicate devices.