(270 days)
No
The device description and performance studies focus on the physical and chemical properties of a resin-based material, with no mention of AI or ML technologies.
No.
The document describes the device as a protective barrier material used to seal and protect gingival tissue during dental procedures, which is a supportive rather than a therapeutic function.
No
The device is described as a protective barrier material used to seal and protect gingival tissue during dental procedures, not to diagnose a condition.
No
The device description clearly states it is a resin-based material supplied in a syringe, which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: armor LC™ is a physical barrier material applied directly to dental tissues and materials in situ (on the patient). It does not analyze samples taken from the body.
- Intended Use: The intended use is to "protect dental materials or tissues" and "seal around and protect the gingival tissue during professional dental procedures." This is a protective, physical function, not a diagnostic one.
- Device Description: The description details a resin material that is applied and cured to form a barrier. There is no mention of analyzing biological samples.
Therefore, armor LC™ falls under the category of a dental device used for protection and isolation during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
armor LCTM is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
Product codes (comma separated list FDA assigned to the subject device)
EIE
Device Description
armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/Gingival tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional dental procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Testing:
- Appearance and handling
- Removal in one piece
- Curing temperature
- Sensitivity to ambient light
- Viscosity
- Depth of cure
- Flexural strength
In all instances, armor LC™ device functioned as intended and met the pre-defined acceptance criteria.
Biocompatibility:
Testing was conducted on the final, finished armor LCTM device in accordance with the international recognized consensus standards listed below and was found to be biocompatible:
- ISO 10993-1 Fourth edition 2009-10-15, Biological evaluation of medical devices .
- ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Uncured material - Direct contact method with exposure of 5 minutes.
- Cured material ISO elution method with exposure of 48 hours
- ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- Uncured material 4 hours
- Cured material 7 days
- ISO 7405 Second edition 2008-12-15, Dentistry Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]
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
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
May 3, 2019
Mavrik Dental Systems Ltd % Sherwyn Davidson QA/RA Director 25 Ha Haroshet Street 6th Fl., Raanana, 4365613 Israel
Re: K182118
Trade/Device Name: armor LCTM Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam And Accessories Regulatory Class: Class I Product Code: EIE Dated: April 3, 2019 Received: April 3, 2019
Dear Sheila Hemeon-Heyer:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Malvina Eydelman, M.D. Director 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) K182118
Device Name armor LCTM
Indications for Use (Describe)
armor LCTM is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
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) |
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."
3
510(k) SUMMARY
Mavrik Dental Systems Ltd.'s armor LCTM Device
| Applicant's name: | Mavrik Dental Systems Ltd. | | | armor LCTM device
(K182118) | Primary Predicate
Triumph Resin Dam
(K151945) | Reference Predicate:
OpalDam
(K971284) | |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Contact Person: | Sherwyn Davidson
QA/RA Director
25 Ha Haroshet Street 6th Fl.,
Raanana, 4365613, Israel
Tel. +972-9-9740100
Fax +972-9-9740101
Sherwyn.davidson@mavrikdental.com | | Device Class | Class I | Class I | Class I | |
| Date Prepared: | April 30, 2019 | | | Classification
Panel | Dental | Dental | Dental |
| Name of Device: | armor LC TM | | | Product Code | EIE | EIE | EIG |
| Common or Usual Name: | Rubber dam and accessories | | Regulation
Description | Rubber dam and
accessories | Rubber dam and
accessories | Dental hand instrument | |
| Classification: | Product Code: | EIE | Regulation
number | 21 C.F.R. §872.6300 | 21 C.F.R. §872.6300 | 21 CFR 872.4565 | |
| | Regulation No: | 21 C.F.R. §872.6300 | Indications for
Use | armor LC™ is a resin-
based, light-cured
protective barrier material
recommended to protect
dental materials or
tissues. | Triumph Resin Dam is a
resin-based, light-cured
protective barrier material
recommended to protect
dental materials or
tissues. | OpalDam resin is used to
protect soft tissue
adjacent to the teeth
during in-office bleaching.
OpalDam is used with
Opalescence Xtra (35%
hydrogen peroxide)
"power" bleaching agent. | |
| | Class: | Class: I | Device Type | Light cured rubber dam | Light cured rubber dam | Light-cured rubber dam | |
| | Classification Panel: | Dental | Composition | Urethane dimethacrylate,
cetyl alcohol, light curing
chemistry, flavor | Urethane acrylates, light-
curing chemistry, silica,
titanium dioxide | Diurethane
dimethacrylate, cetyl
alcohol, light-curing
chemistry, titanium
dioxide | |
| Predicate Device: | Primary predicate: Triumph Resin Dam (K151945)
Reference predicate: OpalDam (K971284) | | Light Cure
Capabilities: | Yes | Yes | Yes | |
| Light Cure
Setting Time: |