(57 days)
No
The device description and performance studies focus on the physical properties and function of a thermoplastic dental guard, with no mention of AI or ML technologies.
Yes.
The device is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding, which is a therapeutic effect.
No
Explanation: The device is indicated for protection against bruxism and reducing damage to teeth, not for diagnosing bruxism or any other condition.
No
The device description clearly states it is a physical dental guard made of thermoplastic resin, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Protect-It Custom Fit Dental Guard's Function: The description clearly states that the device is a physical guard worn on the teeth to protect against the mechanical effects of teeth grinding (bruxism). It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is for physical protection and reduction of damage to teeth, not for diagnosing or monitoring a medical condition through laboratory analysis.
Therefore, the Protect-It Custom Fit Dental Guard falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
Protect-It Custom Fit Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is made of a single thermoplastic resin, ethylene vinyl acetate copolymer, EVA, which is easily molded to the teeth when heated. It is a full-occlusal guard worn on the upper teeth, providing a cushion to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth associated with bruxism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (specifically upper teeth for wearing the guard)
Indicated Patient Age Range
Age 18 and up
Intended User / Care Setting
lay people / 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 Testing: DOC Brands, Inc. conducted an in-home use test (IHUT) which validated that the design of Protect-It Custom Fit Dental Guard meets the intended use and performance expectations of the device.
Biocompatibility Testing:
- In-vitro Cytotoxicity according to ISO 10993-5:2009(E). Results showed the tested device, the cited subject device, is non-cytotoxic.
- Skin Sensitization according to ISO 10993-10:2021(E). Results showed the tested device, the cited subject device, is a non-sensitizer.
- Intracutaneous Reactivity according to ISO 10993-23:2021(E). Results showed the tested device, the cited subject device, was non-reactive under the conditions of the study.
- Oral Mucosa Irritation according to ISO 10993-23:2021(E). Results showed the tested device, the cited subject device, was a non-irritant under the conditions of the study.
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
N/A
0
Image /page/0/Picture/0 description: The image shows 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.
October 7, 2022
DOC Brands, Inc. Eric Mowell Vice President Marketing and Product Development 407 E. Lancaster Avenue Wayne, Pennsylvania 19087
Re: K222424
Trade/Device Name: Protect-It Custom Fit Dental Guard Regulatory Class: Unclassified Product Code: OBR Dated: August 11, 2022 Received: August 11, 2022
Dear Eric Mowell:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
K222424 - Eric Mowell
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, 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) K222424
Device Name Protect-It Custom Fit Dental Guard
Indications for Use (Describe)
Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
DOC Brands, Inc.'s Protect-It Custom Fit Dental Guard (K222424)
510(k)'s Owner's Name, Address, Phone Number:
DOC Brands, Inc. 407 E. Lancaster Avenue Wayne, PA 19087 Phone: 833-362-2763
Contact Person and Date Prepared:
Eric Mowell DOC Brands, Inc., VP Marketing and Product Development Date: August 10, 2022
Subject Device
Device Trade Name: Protect-It Custom Fit Dental Guard Device Common or Usual Name: dental quard, nightquard Classification Name: Mouthguard, Over-the-Counter Regulation Number: N/A Product Code and Class: OBR; unclassified Classification Panel: Center for Devices and Radiological Health; Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Predicate Device
Trade Name: Ready-Fit Disposable Dental Guard Applicant: DenTek Oral Care, Inc. Classification Name: Mouthquard, Over-the-Counter Requlation Number: N/A Product Code and Class: OBR; unclassified 510(k) Number: K151149
Reference Device - used in device equivalence comparison
Trade Name: Custom Comfort Nightguard Version 2 Applicant: DenTek Oral Care, Inc. Classification Name: Mouthguard, Over-the-Counter Requlation Number: N/A Product Code and Class: OBR; unclassified 510(k) Number: K091660 Current Marketed Name: DenTek Professional Fit Dental Guard
Reference Device - used to substantiate after-market biological performance of EVA material
Trade Name: Ora-GUARD Dental Grind Guard Applicant: Bite Tech Inc. Classification Name: Mouthguard, Over-the-Counter Regulation Number: N/A
4
Product Code and Class: OBR; unclassified 510(k) Number: K150492
Subject Device Description
Protect-It Custom Fit Dental Guard is an over-the-counter device to be used by lay people for protection aqainst the effects of nighttime teeth grinding. It is made of a single thermoplastic resin, ethylene vinyl acetate copolymer, EVA, which is easily molded to the teeth when heated. It is a full-occlusal guard worn on the upper teeth, providing a cushion to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth associated with bruxism.
Indications For Use/Intended Use
The subject device, Protect-It Custom Fit Dental Guard, is an over-the-counter device, indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.
The predicate device, DenTek's Ready-Fit Disposable Dental Guard, is an over-thecounter device and has the exact same indication for use and intended use as the subject device. The predicate is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.
Technological Characteristics
The subject device, Protect-It Custom Fit Dental Guard is a full occlusal, dental quard made of a single thermoplastic resin, ethylene/vinyl acetate copolymer (EVA), which forms easily to the teeth when heated. By design, it effectively cushions the teeth and keeps them apart during sleep, thus reducing the damage to teeth associate with nighttime teeth grinding. The heat and form process is a commonly used method for fitting full occlusal mouth guards. The referenced device, DenTek's Custom Comfort Dental Guard Version 2 (K091660) is an example of a guard of similar design (shape and size) that is a heat and form dental guard.
The predicate device, DenTek's Ready-Fit Disposable Dental Guard, is a posteriorocclusive mouth-guard, consisting of two bite pads made of a single thermoplastic resin, ethylene/methyl acrylate copolymer (EMA), which are connected by a buccal band that aids in fit and retention. The predicate is a ready to wear, one size fits all design. It has the same intended use as the subject device, to reduce damage to teeth by cushioning them and keeping them apart during nighttime teeth grinding. Thus, the subject device and the predicate device have the exact same technological operating principles. The technological/design differences between Protect-It Custom Fit Dental Guard and the predicate, Ready-Fit Disposable Dental Guard, are minor and do not raise any new questions of safety or effectiveness. Therefore, the subject device is technologically
5
equivalent to the predicate device. Both the subject device and the predicate device are indicated for over-the-counter use, for age 18 and over.
Substantial Equivalence Discussion
The following table compares the Protect-It Custom Fit Dental Guard to the predicate device with respect to intended use and technological characteristics. It demonstrates the basis for the determination of substantial equivalence. The addition of the reference device comparison presents another substantially equivalent dental guard that is on the market today.
Any minor differences are explained in the narrative below the table.
DOC Brands, Inc. Protect-It Custom Fit Dental Guard vs DenTek Oral Care Inc.'s Ready-Fit Disposable Dental Guard - K151149
| | Subject Device
Protect-It Custom
Fit Dental Guard
(K222424) | Predicate Device
Ready-Fit Disposable
Dental Guard
(K151149) | Reference Device
Custom Comfort
Nightguard Version 2
(K091660) | Differences |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | DOC Brands, Inc. | DenTek Oral Care, Inc. | DenTek Oral Care, Inc. | |
| 510(k) # | K222424 | K151149 | K091660 | |
| Device
Classification
Name | Mouthguard, Over-the-
Counter | Mouthguard, Over-the-
Counter | Mouthguard, Over-the
Counter | NONE |
| Regulation # | None Applicable | None Applicable | None Applicable | NONE |
| Product Code | OBR | OBR | OBR | NONE |
| Regulatory
Class | Not Classified | Not Classified | Not Classified | NONE |
| Device
Description | Full-occlusion,
single material,
injection molded
one-shot, heat and
form moldable
material. | Partial-occlusion, single
material, injection
molded one-shot, bite
tubes connected by
buccal band, ready to
wear. | Full-occlusion, two
materials, injection
molded - two shot; hard
base with moldable heat
and form material in top
layer. Formed using the
provided fitting tray. | Specific design
differences are
addressed
further below. |
| Packaging
Content | Package contains 4
dental guards and
one storage case.
IFU on outer carton. | Package contains 12 or
16 disposable dental
guards. No IFU
needed. | Package contains 1
dental guard, 1
disposable fitting tray,
one storage case and
IFU. | No performance
impact. |
| DESIGN | Subject Device | Predicate Device | Reference Device | Differences |
| | Protect-It Custom Fit | Ready-Fit Disposable | Custom Comfort | |
| | Dental Guard
(K222424) | Dental Guard
(K151149) | Nightguard Version 2
(K091660) | |
| Indications
for Use and
Intended Use | Protect-It Custom Fit
Dental Guard is
indicated for protection
against bruxism or
nighttime teeth
grinding. It is intended
to reduce damage to
teeth associated with
bruxing or nighttime
teeth grinding. | Ready-Fit Disposable
Dental Guard is
indicated for protection
for nighttime teeth
grinding or bruxism. It is
intended to reduce
damage to teeth by
cushioning them and
keeping them apart
during grinding. | Custom Comfort
Nightguard Version 2 is
indicated for protection
against bruxism or
nighttime teeth grinding.
It is intended to reduce
damage to the teeth
and to prevent the noise
associated with bruxing
or grinding. | NONE |
| OTC or RX | OTC | OTC | OTC | NONE |
| User
Population | Age 18 and up | Age 18 and up | Age 18 and up | NONE |
| Technologi-
cal
Characteris-
tics | Flexible guard used as a
barrier or cushion
between upper and
lower teeth. | Flexible guard used as
a barrier or cushion
between upper and
lower teeth. | Flexible guard used as
a barrier or cushion
between upper and
lower teeth. | NONE |
| Duration of
Use | Reusable | Disposable after one
night | 6 month wear
guarantee | 1Minor (IHUT
conducted to
confirm reusable
- see Section
18: Bench
Testing).
Subject device
has no wear
guarantee. |
| Materials | Comprised completely
of moldable thermo-
plastic resin - EVA
(ethylene/vinyl acetate
copolymer)
Taisox 7350 M | Comprised completely
of thermo-plastic resin,
EMA (ethylene/methyl
acrylate copolymer)
Elvaloy 1609 AC | 1st shot Base made of
thermo-plastic resin
(EMA) Elvaloy 1609;
2nd shot Upper
moldable layer made
of EVA - Elvax 150 | 2Minor
(biocompatibility
testing confirms
the EVA resin of
the subject
device is
appropriate for
its intended use) |
| Tensile
Strength at
Break | 14.71 MPa | 13.0 MPa | 13.0 MPa | |
| Tensile
Strength at
Yield | 4.41 MPa | 80 MPa | 81 MPa | |
| Elongation at
Break | 800 % | 740 % | 740 % | |
| Hardness
Shore A | 88 | 97 | 97 | |
| Hardness
Shore D | 38 | 46 | 46 | |
| | Subject Device | Predicate Device | Reference Device | Differences |
| DESIGN | Protect-It Custom Fit
Dental Guard
(K222424) | Ready-Fit Disposable
Dental Guard
(K151149) | Custom Comfort
Nightguard Version 2
(K091660) | |
| Materials
(cont.) | Taisox 7350 M | EMA - Elvaloy 1609 AC | EMA - Elvaloy 1609
EVA - Elvax 150 | |
| Melt Index | 2.5 g/10 min | 6.0 g/10 min | 6.0 g/10 min
43 g/10 min | |
| Density | 0.938 g/cm3 | 0.93 g/cm3 | 0.93 g/cm3
0.957 g/cm3 | |
| Fit | Full occlusion, heat and form for custom fit, worn
on upper teeth. Excess
length or wall height may
be trimmed by user for
one size fits all
compatibility. | Posterior occlusion,
ready-to-wear, one size
fits all, worn on
upper or lower teeth | Full occlusion, heat
and form with forming
tray for custom fit.
Worn on upper teeth.
Excess length of arch
may be trimmed by
user. | 3Minor (full
occlusion, heat
and form design
is similar to the
reference
device) |
| Dimensions
(l x w x h) | 5.25cm L x 6.614cm W x
1.814cm H | 3.8cm L x 3.9cm W x
1.9cm H | 3.8cm L x 6.3cm W x
0.9cm | 4Minor (subject
is similar to the
predicate and
reference
devices) |
| Weight | 0.3 ounce (10 grams) | 0.04 ounce (1.33 grams) | 0.2 ounce (6 grams) | 5Minor (full
occlusal vs
partial occlusal
accounts for
weight
differential in
subject vs
predicate) |
| Sterilization | Device is not sold sterile | Device is not sold sterile | Device is not sold
sterile | NONE |
| Method of
cleaning | Before fitting, wash in
warm water and try on;
wash in warm water after
each use and store in
case provided | Disposable, no
instructions for cleaning
included | Brush with toothpaste
or mouthwash and
rinse in cool water
after each use. | 6Similar to
reference device |
6
7
The table above identifies a few minor differences between the proposed device and the cited predicate and referenced device. 1. The specific durations of use per the products' labeling differ. However, the duration of use does not affect the safety or effectiveness of the subject device. Protect-It Custom Fit Dental Guard was verified to be reusable in a home use simulation (bench test), the report for which is provided in this submission (Section 18: Bench Testing). The longevity of the device will depend on the force of the grinding of the user. No wear guarantee is provided. 2. While the contact material for the subject and predicate devices is a single ethylene-based copolymer, the exact resins are not identical. The subject device uses a similar EVA material as in the moldable layer of the reference device. The appropriateness of the
8
subject device's resin for use in a dental guard was demonstrated through biocompatibility testing of the finished guard, which is provided in this application. See Section 15: Biocompatibility and Attachments 6-9. Biocompatibility test reports (four tests). 3. The predicate utilizes a ready-to-wear, posterior-occlusion design whereas the subject device, like the reference device, utilizes a full-occlusion design, fit with the heat and form process. All are effective for the intended use. 4. The measurements of the subject device differ from the predicate due to the overall design. The bite radius of the subject device is wider than the predicate because the predicate has a narrow strap between the bite pads that does not retain its in-use shape. The subject is longer as it is designed to be trimmed if needed by the user. Though not identical, the width measurement of the subject device is similar to the cited reference device. 5. The subject device has a higher overall weight due to the full occlusal design versus the posterior-occlusal design of the predicate. The weight of the subject device and the reference device are similar. 6. The subject device and reference device have similar instructions for inspecting and cleaning after each use.
The subject device and the predicate device have the same indications for use and intended use, the same user population and the same technological characteristics.
The minor differences between the subject device and the cited predicate do not raise different questions of safety or effectiveness and this application establishes that the subject device is as safe and effective as the predicate. Thus, the subject device, Protect-It Custom Fit Dental Guard is substantially equivalent to the predicate device, Ready-Fit Disposable Dental Guard. The addition of the reference device comparison presents another substantially equivalent dental guard that is on the market today.
In summary, although they fit the mouth in a slightly different manner, the subject device and the predicate device have the same technological characteristics and intended use, to protect the teeth from the damage of night-time grinding them and keeping them apart.
In accordance with section 513(i)(1)(A) of the FDCA, a device is substantially equivalent (SE) when it has the same intended use and technological characteristics as a legally marketed predicate device. As demonstrated in this traditional 510(k), any differences between the subject device and the cited predicate do not raise different questions of safety or effectiveness and this application establishes that the device is as safe and effective as the predicate.
Non-Clinical Performance Testing
Bench Testing
DOC Brands, Inc. conducted an in-home use test (IHUT) which validated that the design of Protect-It Custom Fit Dental Guard meets the intended use and performance expectations of the device. See Section 18: Bench Testing, Attachment 4A: Bench Test Protocol, 4B: Bench Test Engineering Study, and Attachment 4C: Bench Test Data.
9
This data supports the subject's substantial equivalence to the predicate.
Biocompatibility Testing
Additionally, the following biocompatibility tests were performed on the subject device.
- In-vitro Cytotoxicity according to ISO 10993-5:2009(E). Results showed the . tested device, the cited subject device, is non-cytotoxic.
- Skin Sensitization according to ISO 10993-10:2021(E). Results showed the . tested device, the cited subject device, is a non-sensitizer.
- Intracutaneous Reactivity according to ISO 10993-23:2021(E). Results showed . the tested device, the cited subject device, was non-reactive under the conditions of the study.
- Oral Mucosa Irritation according to ISO 10993-23:2021(E). Results showed the ● tested device, the cited subject device, was a non-irritant under the conditions of the study.
These tests further demonstrate the subject device's substantial equivalence to the cleared predicate device.
Conclusion
The Protect-It Custom Fit Dental Guard has the same indications for use and intended use, and the same technological characteristics and principles of operation as the predicate device, Ready-Fit Disposable Dental Guard. The relevant information on biocompatibility and the performance testing, confirm that the Protect-It Custom Fit Dental Guard fulfills its intended use as safely and effectively as the legally marketed predicate device. The Protect-It Custom Fit Dental Guard, the subject device, is therefore substantially equivalent to the predicate device, Ready-Fit Disposable Dental Guard.