els extra low shrinkage® composite & els extra low shrinkage® flow
Device Facts
| Record ID | K240823 |
|---|---|
| Device Name | els extra low shrinkage® composite & els extra low shrinkage® flow |
| Applicant | Saremco Dental AG |
| Product Code | EBF · Dental |
| Decision Date | Jun 27, 2024 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Light-cured, methacrylate-based resin restorative materials; used by dentists in clinical settings to reconstruct or correct natural dentition. Input: uncured resin paste applied to tooth defects. Transformation: light-curing (400-500 nm) initiates polymerization, hardening the material into a permanent restoration. Output: cured, radiopaque, microhybrid composite filling. Benefits: low shrinkage stress, biocompatible, aesthetic tooth-colored restoration. Healthcare providers use the material to fill cavities, repair fractures, or attach indirect restorations, directly impacting clinical outcomes by restoring tooth function and aesthetics.
Clinical Evidence
No human clinical testing performed. Substantial equivalence supported by bench testing per ISO 4049:2009 (compressive strength, flexural strength, water sorption, solubility, depth of cure, radiopacity) and biocompatibility testing per ISO 10993-1:2018 and ISO 7405:2018.
Technological Characteristics
Light-cured, radiopaque microhybrid composite. Composition: methacrylate-based resins, dental glass-filler, photo initiators, pigments. Curing wavelength: 400-500 nm. Complies with ISO 4049:2009 (Type 1, Class 2, Group 1 & 2 for composite; Type 2, Class 2, Group 1 for flow). Non-sterile.
Indications for Use
Indicated for patients with permanent dentition requiring restoration. els extra low shrinkage® composite is indicated for class I-V cavity restorations, indirect restorations (inlays, onlays, veneers), aesthetic corrections (interdental spaces, enamel hypoplasia, discolorations), and splinting. els extra low shrinkage® flow is indicated for minimally invasive restorations, small cavities, extended fissure sealing, undercut cavities, class III-V restorations (including wedge-shaped defects and cervical caries), repair of fillings/veneers/temporary restorations, first layer for class I/II fillings, interlocking loosened teeth, and adhesive attachment of indirect restorations.
Regulatory Classification
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.
Predicate Devices
- DENU Composite Resin (K213339)
Reference Devices
Submission Summary (Full Text)
{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)
K240823
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
# K240823 – 510(k) Summary
| Submitter | Saremco Dental AG<br>Gewerbestrasse 4<br>CH-9445 Rebstein, Switzerland<br>Establishment Reg. No. 3008582054 |
|-----------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Christoph Evers<br>Head of R&D<br><b>Phone</b> +41 71 775 80 90<br><b>Fax</b> +41 71 775 80 99<br><b>E-Mail</b> christoph.evers@saremco.ch |
| Official Correspondent | Nevine Erian |
|------------------------|----------------------------------------|
| | Regulatory Consultant |
| | <b>BQC Consulting, LLC</b> |
| | 24341 Barbados Dr. |
| | Dana Point, CA 92629 |
| | <b>Phone</b> (949) 370-7155 |
| | <b>Fax</b> (949) 240-8829 |
| | <b>E-mail</b> nevine@bqcconsulting.com |
Date Prepared June 24, 2024
| Trade/Device Names | els extra low shrinkage® composite<br>els extra low shrinkage® flow |
|--------------------------------------------|---------------------------------------------------------------------|
| Common Name | Tooth Shade Resin Material |
| Classification Name &<br>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<br>Resin | Brilliant<br>Componeer | Rationale for Difference |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | els extra low<br>shrinkage®<br>composite is a<br>restorative<br>material intended<br>for the<br>reconstruction or<br>correction of<br>natural dentition.<br>- Restoration of<br>class I, II, III, IV<br>and V cavities on<br>anterior and<br>posterior teeth<br>- Indirect anterior<br>and posterior<br>restorations<br>including inlays,<br>onlays and<br>veneers<br>- Aesthetic<br>corrections of<br>interdental<br>spaces, enamel<br>hypoplasia,<br>discolorations<br>- Splinting | DENU Composite<br>Resin is indicated<br>for use in:<br>- Direct anterior<br>and posterior<br>restorations<br>- Core buildup<br>- Splinting<br>- Indirect anterior<br>and posterior<br>restorations<br>including inlays,<br>onlays and<br>veneers | Clinical indications<br>- Restoration of<br>caries defects<br>- Reconstruction<br>of lost tooth<br>substance due to<br>attrition,<br>abrasion, erosion<br>- Restoration of<br>tooth fractures<br>- Correction of<br>anatomical<br>malformation<br>Cosmetic<br>indications<br>- Optimisation of<br>old composite<br>restorations<br>- Extending<br>incisors<br>- Correction of<br>malpositioned<br>teeth<br>- Cosmetic<br>corrections for<br>tooth<br>discolouration or<br>incorrect shading<br>- Closure of<br>diastema | The verbiage describing the indications<br>for Use of els composite and the<br>predicate, DENU Composite resin, is<br>slightly different. The wording used by<br>the primary predicate (namely: "Direct<br>anterior and posterior restorations")<br>describes a much broader field in<br>comparison to "Restoration of class I, II,<br>III, IV and V cavities on anterior and<br>posterior teeth". The indications<br>"Indirect anterior and posterior<br>restorations including inlays, onlays and<br>veneers" and "Splinting" are equal on<br>both sides.<br>The formulations describing the<br>indications for the use of els composite<br>and the predicate "Brilliant Componeer"<br>are different. The wording of the<br>predicate (namely: "<br>- Restoration of caries defects<br>- Reconstruction of lost tooth substance<br>due to attrition, abrasion, erosion<br>- Restoration of tooth fractures<br>- Correction of anatomical<br>malformation") also describes a much<br>broader range compared to the<br>indications of the els composite<br>"Restoration of class I, II, III, IV and V<br>cavities on anterior and posterior<br>teeth", "Indirect anterior and posterior<br>restorations including inlays, onlays and<br>veneers" and "Splinting".<br>The other indications of the predicate<br>device "Brilliant Componeer" in<br>comparison to the proposed els<br>composite hybrid list the esthetic<br>corrections: (Cosmetic indications<br>- Optimization of old composite<br>restorations<br>- Extending incisors<br>- Correction of mal-positioned teeth<br>- Cosmetic corrections for tooth<br>discoloration or incorrect shading<br>- Closure of diastema"),<br>whereby a much broader range of<br>esthetic corrections is also mentioned |
| Attribute | els composite | DENU Composite<br>Resin | Brilliant<br>Componeer | Rationale for<br>Difference |
| Physical Properties | | | | |
| Physical State | Uncured resin<br>paste | Uncured resin<br>paste | Polymerized<br>prefabricated<br>hybrid composite<br>enamel shell | After light curing,<br>els composite and<br>Denu Composite<br>Resin perform the<br>same as Brilliant<br>Componeer |
| Material Color | Various shades | Various shades | Various shades | Shade differences<br>do not affect device<br>performance |
| Packaging | Prefilled syringes<br>& tips | Prefilled syringes | Preformed shells<br>in box | Packaging<br>differences do not<br>impact cured<br>device performance |
| Compressive<br>Strength | Avg. = 289.8 MPa | 187.4 MPa | 285 MPa | Though different<br>compressive<br>strength values, in<br>subject and<br>predicate devices,<br>higher strength of<br>els composite does<br>not affect<br>substantial<br>equivalence. |
| Surface Hardness | Avg. = 76<br>Vicker's Hardness | 43.86 KHN | Unknown | Surface hardness<br>values are not<br>comparable due to<br>lack of available<br>data. Vicker's<br>Hardness is a<br>typical standard for<br>composites. |
| Performance Testing | ISO 4049 | ISO 4049 | ISO 4049 | |
| Flexural Strength | Avg. = 116.3 MPa | 135.74 MPa | 125.4 MPa | Though different<br>values, subject and<br>predicate devices<br>meet same ISO<br>4049 performance<br>requirements |
| Attribute | els composite | DENU Composite<br>Resin | Brilliant<br>Componeer | Rationale for<br>Difference |
| Water Sorption | Avg. =14.7 µg/mm3 | 18.48 µg/mm3 | 18.2 µg/mm3 | Though different<br>values, subject and<br>predicate devices<br>meet same ISO<br>4049 performance<br>requirements |
| Solubility | Avg. = 0.8 µg/mm3 | 0.82 µg/mm3 | 0.3 µg/mm3 | Though different<br>values, subject and<br>predicate devices<br>meet same ISO<br>4049 performance<br>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<br>values, subject and<br>predicate devices<br>meet same ISO<br>4049 performance<br>requirements |
| Material<br>Comparison | | | | |
| Chemical<br>Characterization | Methacrylate-based<br>resins, dental glass-<br>filler, photo<br>initiators<br>and pigments. | Methacrylate-<br>based resins,<br>dental glass-filler,<br>photo initiators<br>and pigments. | Methacrylate-<br>based resins,<br>dental glass-filler,<br>photo initiators<br>and pigments. |…
