(241 days)
No
The device description and performance studies focus on the material properties and biological effects of a periodontal wound dressing, with no mention of AI or ML technologies.
No.
The device is a wound dressing that protects injured tissue, which is a supportive function, rather than directly treating a disease or condition. Its bacteriostatic property is a characteristic, not its primary intended therapeutic action.
No
Explanation: The device is described as a periodontal wound dressing intended to protect injured periodontal tissue and is used by dental professionals. Its function is to cover and protect, not to diagnose a condition.
No
The device description clearly states it is a thermoplastic and non-resorbable medical device with a physical form (granules) that hardens. This indicates a physical material, 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 to "protect injured periodontal tissue as surgical sites." This is a direct therapeutic application on the patient's body.
- Device Description: The description details a physical material used as a wound dressing.
- Lack of In Vitro Diagnostic Activities: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The "in vitro conditions" mentioned in the description refer to testing of the material's properties (bacteriostatic activity), not its use as a diagnostic tool.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is applied to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
Elemental Granulate is a periodontal wound dressing intended to protect injured periodontal tissue at surgical sites.
Product codes
OLR, EMA
Device Description
Elemental Granulate is a thermoplastic and non-resorbable medical device, which under in vitro conditions is found to be bacteriostatic. Material consistency is plastic-like and highly moldable after heating. Hardening starts 30 to 60 seconds after taking it away from the heat source. Hardens into a rigid material after approximately 90 seconds. Individual granules may slightly differ in size. For use only by a dental professional in the recommended indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal tissue (at surgical sites)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
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
The following non-clinical performance and safety testing were conducted to support the substantial equivalence with the predicate device:
- Biocompatibility assessment and testing was conducted in conformity to ISO 10993 standards, including a toxicological risk assessment per ISO 10993-17.
- . Test report according to ISO 22196 to demonstrate the antibacterial activity on Elemental Granulate.
- Evaluation of plastics potency to inhibit oral biofilm formation, malodor, or decrease viability of oral pathobionts.
- . Test report to show a reduction in total biofilm by making use of Elemental Granulate in comparison to other dental materials, while the (proliferation of) humans cells are not affected.
- Theoretical summative evaluation resulting in a usability engineering risk assessment.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 3, 2025
Zinkh NV Emiel Lippens Product manager Zuiderlaan 1-3 PO box: 8 Gent, 9000 BELGIUM
Re: K241283
Trade/Device Name: Elemental Granulate Regulatory Class: Unclassified Product Code: OLR, EMA Dated: December 23, 2024 Received: December 23, 2024
Dear Emiel Lippens:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
2
assistance/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 -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Elemental Granulate
Indications for Use (Describe)
Elemental Granulate is a periodontal wound dressing intended to protect injured periodontal tissue as surgical sites.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K241283
510(k) SUMMARY FOR ELEMENTAL GRANULATE
1. SUBMITTER
| 2. DEVICE | |
|---|---|
| Date prepared: | 03 January 2025 |
| Contact person: | |
| Email: | |
| Telephone Number: | EMIEL LIPPENS |
| EMIEL.LIPPENS@ZINKH.COM | |
| +32 478 55 37 57 | |
| Zinkh NV | |
| Zuiderlaan 1-3 | |
| Post office box 8 | |
| 9000 Ghent | |
| Belgium | |
| Proprietary Name: | Elemental Granulate |
|---|---|
| Classification name: | Oral wound dressing |
| Device Classification: | Unclassified and Class II following 21 CFR 872.3275 |
| Product Code: | OLR, EMA |
3. PREDICATE DEVICE
| Predicate device | 510(k) number | Applicant |
|---|---|---|
| COE PAK (Auto mix, Regular or | ||
| Hard set) | K881422 | COE Laboratories, Inc. |
4. DEVICE DESCRIPTION
Elemental Granulate is a thermoplastic and non-resorbable medical device, which under in vitro conditions is found to be bacteriostatic. Material consistency is plastic-like and highly moldable after heating. Hardening starts 30 to 60 seconds after taking it away from the heat source. Hardens into a rigid material after approximately 90 seconds. Individual granules may slightly differ in size. For use only by a dental professional in the recommended indications.
5. INDICATIONS FOR USE
Elemental Granulate is a periodontal wound dressing intended to protect injured periodontal tissue at surgical sites.
6. COMPARISON OF INDICATIONS FOR USE WITH THE PREDICATE DEVICE
The intended use of the device is the same as the intended use of the predicate device, since both medical devices are intended as periodontal wound dressing.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Elemental Granulate has similarities with the predicate device on aspects such as anatomical site, environmental use, performance, biocompatibility, and microbiological status resulting in a similar safety and performance profile and are both easy-to-use and moldable devices for dental (health professionals) to be used within patients requiring a periodontal wound dressing, mostly post-
5
510(k) SUMMARY FOR ELEMENTAL GRANULATE
surgery. Elemental Granulate differs in chemical composition, physical properties and therefore also in the preparatory handling steps. These differences are summarized in more detail below.
| Feature -
Technological
| characteristics | Submission Device - Elemental Granulate | Predicate device- COE-PAK | Identified differences |
|---|---|---|---|
| Human Factors | Different preparatory handling steps: | ||
| mixing within heat up water or sterile saline | |||
| to approximately 90°C or 194°F by stirring | |||
| with a non-plastic tool; and reworking can be done by re-heating. | Different preparatory handling | ||
| steps: | |||
| mixing with a spatula | |||
| and/or a mixing tip; and tackiness of the mixture | |||
| needs to be checked and | |||
| therefore lubrication of | |||
| the fingers might be | |||
| required. | Similar, for Elemental | ||
| Granulate there is no | |||
| need to test the | |||
| tackiness, which is | |||
| needed for the predicate | |||
| device. All other steps | |||
| are comparable between | |||
| the devices. | |||
| Material and | |||
| design | Thermoplastic polymer with antibacterial additive | ||
| granules, free of (zinc oxide-)eugenol, to ensure | |||
| respectively the moldability when used in | |||
| combination with water or sterile saline solution of | |||
| approximately 90°C or 194°F and bacteriostatic | |||
| properties (ISO 22196). | A reaction between a catalyst | ||
| (fluid paste; metallic oxide or | |||
| more specific zinc oxide) and a | |||
| base (paste; fatty acid), which | |||
| contains non-viable biological- | |||
| derived ingredients (plant- | |||
| derivates), to ensure a | |||
| moldable mixture. | Similar. For COE-PAK a | ||
| reaction between | |||
| metallic oxide and fatty | |||
| acid is needed to ensure | |||
| a moldable mixture, | |||
| while Elemental | |||
| Granulate becomes | |||
| moldable by heating. | |||
| Compatibility | |||
| with other | |||
| products | For the dental health professional and within the | ||
| preparatory handling, it is important to not use | |||
| plastic and to wear personal protective equipment, | |||
| whereby it may stick and therefore latex gloves | |||
| and/or wetting the gloves are recommended. For | |||
| the intended patient population, it is important to | |||
| note that a slight discoloration of the material | |||
| might take place in the patient's mouth due to food | |||
| consumption or use of antiseptics. | No specific instructions other | ||
| than that COE-PAK should be | |||
| used by a dental professional | |||
| only. | Similar between the | ||
| devices, but for | |||
| Elemental Granulate it | |||
| was decided to provide a | |||
| more detailed | |||
| instruction related to | |||
| compatibility with other | |||
| products. |
8. NON-CLINICAL TESTING
The following non-clinical performance and safety testing were conducted to support the substantial equivalence with the predicate device:
- Biocompatibility assessment and testing was conducted in conformity to ISO 10993 standards, including a toxicological risk assessment per ISO 10993-17.
- . Test report according to ISO 22196 to demonstrate the antibacterial activity on Elemental Granulate.
- Evaluation of plastics potency to inhibit oral biofilm formation, malodor, or decrease viability of oral pathobionts.
- . Test report to show a reduction in total biofilm by making use of Elemental Granulate in comparison to other dental materials, while the (proliferation of) humans cells are not affected.
- Theoretical summative evaluation resulting in a usability engineering risk assessment.
9. CLINICAL TESTING
Clinical testing, although available, was not needed in support of this 510(k) application.
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10. CONCLUSIONS
Based on similarity in technology and the same indication for use as well as the results of performance testing, Elemental Granulate is substantially equivalent to the predicate device COE-PAK. Therefore, the subject device is safe and effective as the predicate device that has been legally marketed in the United States.