(193 days)
No
The description focuses on the physical properties and materials of a custom-fit mouth guard, with no mention of AI or ML technology.
No
The device is intended for protection against bruxism and teeth grinding by creating a barrier and protecting overall occlusion, not for treating a disease or condition.
No
The device is described as a protective custom-fit mouth guard intended to create a barrier between teeth to prevent bruxism and teeth grinding, not to diagnose a condition.
No
The device description clearly states it is a physical mouth guard made from biocompatible materials, intended for patient contact and protection against bruxism and teeth grinding. It is a hardware device.
Based on the provided information, the JS Dental Lab Mouth Guard is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for protection against bruxism and teeth grinding by creating a physical barrier between teeth. This is a mechanical function, not a diagnostic one.
- Device Description: The device is a physical, custom-fit mouth guard made of biocompatible materials. It acts as a protective barrier.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition based on in vitro analysis.
- Predicate Device: The predicate device (K121365) is also a mouthguard/nightguard, which are typically classified as Class II medical devices for mechanical protection, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The JS Dental Lab Mouth Guard does not perform any such function.
N/A
Intended Use / Indications for Use
The JS Dental Lab Mouth Guard is intended for protection against bruxism and teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.
Product codes
MOC, MQC
Device Description
The JS Dental Lab Mouth Guard (herein referred to as Subject Device) is a patient contact protective custom-fit mouth guard that covers the upper teeth and lower teeth to prevent premature tooth wear and noise caused due to bruxism and teeth grinding. It fits over upper teeth or lower teeth during sleep. The Subject Device can offset the effects of bruxing or teeth grinding while protecting teeth from daily wear and tear. The Subject Device is created based on the user's teeth impression and manufactured using the biocompatible material, equivalent to the Thermoformed Mouthguards/Nightguards (herein referred to as Predicate Device, K121365).
The Subject Device contains biocompatible materials, namely, Erkodur or Splint Biocryl, Erkoloc-Pro, Erkoflex-95, EVA Based Clear Mouthguard Material and BIOPLAST and is available in four different variations. All the biocompatible materials used are ISO-certified, BPA-free, and are cleared for dental use in humans.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper teeth and lower teeth
Indicated Patient Age Range
Not Found
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)
Bench Performance Testing: The physical properties for the materials for the Subject Device have been provided by the material manufacturer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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.
July 16, 2021
Ampower Dental Laboratories, LLC % Parul Chansoria CEO and Founder Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan, Wyoming 82801
Re: K210011
Trade/Device Name: JS Dental Lab Mouth Guard Regulatory Class: Unclassified Product Code: MOC Dated: June 3, 2021 Received: June 8, 2021
Dear Parul Chansoria:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 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-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 -S
Michael E. Adjodha, M.ChE. 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
2
Indications for Use
510(k) Number (if known) K210011
Device Name JS Dental Lab Mouth Guard
Indications for Use (Describe)
The JS Dental Lab Mouth Guard is intended for protection against bruxism and teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.
| 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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5.1. Submitter's Information
Ampower Dental Laboratories LLC, 3423 Investment Blvd Suite 11, Hayward, CA 94545 USA
Contact Person
Parul Chansoria, MS, RAC, CQA CEO & Founder, Elexes Medical Consulting Telephone: + 408-475-8091 E-mail: parul@elexes.com
Date Prepared: June 03, 2021.
5.2. Device Information
Common/Usual name: Mouthguard Trade Name: JS Dental Lab Mouth Guard Regulation Name: Mouthguard, Prescription Regulatory Class: Class II Review Panel: Dental Product Code: MQC
5.3. Predicate Device Information
| Table 1: Predicate Device Information | |||||
|---|---|---|---|---|---|
| Company | Predicate | ||||
| Priority | Product | 510(k) Number | |||
| Glidewell | |||||
| Laboratories - | |||||
| Sleep Devices | |||||
| Group | Primary | Thermoformed | |||
| Mouthguards/Nightguar | |||||
| ds | K121365 | ||||
| Erkodent Erich | |||||
| Kopp GmbH | Reference | Thermoforming Sheet | |||
| Materials | K200125 |
5.4. Device Description
The JS Dental Lab Mouth Guard (herein referred to as Subject Device) is a patient contact protective custom-fit mouth guard that covers the upper teeth and lower teeth to prevent premature tooth wear and noise caused due to bruxism and teeth grinding. It fits over upper teeth or lower teeth during sleep. The Subject Device
4
can offset the effects of bruxing or teeth grinding while protecting teeth from daily wear and tear. The Subject Device is created based on the user's teeth impression and manufactured using the biocompatible material, equivalent to the Thermoformed Mouthguards/Nightguards (herein referred to as Predicate Device, K121365).
The Subject Device contains biocompatible materials, namely, Erkodur or Splint Biocryl, Erkoloc-Pro, Erkoflex-95, EVA Based Clear Mouthguard Material and BIOPLAST and is available in four different variations. All the biocompatible materials used are ISO-certified, BPA-free, and are cleared for dental use in humans.
5.5. Indications for Use
The Subject Device (The JS Dental Mouth Guard) is intended for protection against bruxism and teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.
5.6. Comparison Of Technological Characteristics With The Predicate Device
A detailed comparison of the Subject Device with the predicate device is given in Table 2. The Indications for Use, key technological characteristics, and operating principle of the Subject Device is equivalent to the Predicate Device, K121365.
| Table 2: Technological Characteristics Comparison | ||||
|---|---|---|---|---|
| Parameters | Subject Device: | |||
| JS Dental Lab Mouth | ||||
| Guard | Predicate Device: | |||
| Thermoformed | ||||
| Mouth Guards | ||||
| (K121365) | Reference Device: | |||
| Thermoforming | ||||
| Sheet Materials | ||||
| (K200125) | Equivalence | |||
| Manufacturer | Ampower Dental | |||
| Laboratories LLC | Glidewell | |||
| Laboratories-Sleep | ||||
| Devices Group | Erkodent Erich | |||
| Kopp GmbH | -- | |||
| Indications for | ||||
| Use | The JS Dental Lab | |||
| Mouth Guard is | ||||
| intended for protection | ||||
| against bruxism and | ||||
| teeth grinding. They | ||||
| create a barrier | ||||
| between the upper and | ||||
| lower dentition to | ||||
| protect the patient's | The Thermoformed | |||
| Mouthguards/Nightg | ||||
| uards are | ||||
| customized devices | ||||
| fit over upper or | ||||
| lower teeth during | ||||
| sleep and can offset | ||||
| the effects of | ||||
| bruxing or clenching | Thermoforming | |||
| Sheet Materials are | ||||
| indicated for the | ||||
| fabrication of | ||||
| orthodontic and | ||||
| dental appliances | Equivalent | |||
| overall occlusion. | while protecting | |||
| teeth from daily | ||||
| wear and tear. | ||||
| Materials | Co-polyester, | |||
| polyurethane, Ethyl | ||||
| Vinyl acetate | ||||
| (Erkodur or Splint | ||||
| Biocryl, Erkoloc-Pro, | ||||
| Erkoflex-95, EVA | ||||
| Based Clear | ||||
| Mouthguard Material | ||||
| and BIOPLAST) | Co-polyester, | |||
| polyurethane, Ethyl | ||||
| Vinyl acetate | ||||
| (Erkoloc | ||||
| Pro, Erkoflex, | ||||
| Erkodur) | Erkoloc-pro (blue / | |||
| green / pink), | ||||
| Erkodur (freeze / - | ||||
| 0M1 /-A1 / -A2 / - | ||||
| A3), Erkoflex (color | ||||
| / freestyle / -95 / - | ||||
| bleach) Erkolign, | ||||
| Erkoplast PLA (-T/- | ||||
| W/-R), Erkolen, | ||||
| Playsafe triple (- | ||||
| light) | Different | |||
| Reusable device | Yes | Yes | Yes | Equivalent |
| Single patient | ||||
| use | ||||
| only | Yes | Yes | Yes | Equivalent |
| Variations of | ||||
| Mouthguard | Thermoformed Night | |||
| Guards | Thermoformed | |||
| Mouthguards/Night | ||||
| Guards | - | Equivalent | ||
| Design | Pre-formed Device | Pre-formed Device | - | Equivalent |
| Method of | ||||
| Manufacturing | Thermo-Molding | |||
| Custom-Fit | Thermo-Molding | |||
| Custom-Fit | Thermo-Molding | |||
| Custom-Fit | Equivalent | |||
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Equivalent |
Confidential
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5.6.1. Similarities
- The Subject Device and the predicate have the same intended use.
- · The design, intended user, and mouth guard materials of the Subject Device are the same w.r.t the Predicate Device.
- The Subject Device and the Predicate Device are reusable devices with an equivalent mode of disinfection method.
- Both the Subject Device and the Predicate Device are supplied non-sterile.
Confidential
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5.6.2. Differences
The differences are in the number of variants, addition of Splint Biocryl in the Subject Device and difference between Erkoflex - 95 and Erkoflex in the Predicate Device does not raise new questions of safety and efficacv.
5.7. Biocompatibility
The materials used by the JS Dental Lab Mouth Guard are equivalent to the Predicate Device and have the same manufacturing process and intended use. The Subject Device is manufactured from biocompatible materials using ISO-certified thermoforming materials from the Erkodent Company and Great Lakes Orthodontics. The materials are purchased from Erkodent Company and Great Lakes Orthodontics. These thermo-moulding materials are BPA-free and are cleared for dental use. The biocompatibility of the materials is confirmed according to ISO 10993-1:2018.
The materials used in the Subject Device have been tested for cytotoxicity, mucosa irritation, sensitization, acute systemic and subchronic toxicity, genotoxicity in compliance with ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 for the intended dental use.
The Material Safety Data Sheet (MSDS) and results of Biocompatibility evaluation report reflect that all the specifications of the materials have met the specified acceptance criteria and support the claim for substantial equivalence and safety and efficacy of the Subject Device.
The Subject Device is a non-sterile dental device available in four different variations as mentioned below.
● JS Dental Lab Hybrid Mouth Guard
This Mouth Guard is made up of a material called Erkoloc-Pro. It is a Hard Night Guard with a hard outer surface and a smooth inner surface. The material Erkoloc-Pro is made up of two mixtures such as Polyethylene Terephthalate (PET-G) on the outside and Thermoplastic Polyurethane (TPU) on the inside. The Predicate Device also uses the same material and proved the biocompatibility in accordance with ISO 10993-1:2018.
● JS Dental Lab Extra Durable Mouth Guard
This Mouth Guard is made up of a material called Erkodur. This one is the hardest Mouth Guard amongst all the ones supplied by Erkodent Company. It has the composition of Polyethylenterephthal (PET - G).
JS Dental Lab Soft Mouth Guard ●
Confidential
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This Mouth Guard is made up of a material called Ethyl Vinyl Acetate (EVA) based clear mouthguard material and BIOPLAST.
● JS Dental Lab Durable Mouth Guard
This Mouth Guard is made up of a material called Erkoflex-95. The material Erkoloc-95 is made up of Ethylenvinylacetat (EVA).
5.8. Bench Performance Testing
The physical properties for the materials for the Subject Device have been provided by the material manufacturer.
5.9. Conclusion
The Subject Device is substantially equivalent to the Predicate Device, Thermoformed Mouth Guards (K121365) in the indications for use and technological characteristics. The minor differences in technological characteristics do not raise any significant questions on the safety and efficacy of the Subject Device.