(171 days)
K 072147
Not Found
No
The summary describes a physical mouthguard made of a specific polymer and its physical properties, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is indicated for use in "protecting the teeth and reduce damage caused by bruxism or nighttime grinding," which is a therapeutic function addressing a medical condition.
No
The device is indicated for protection of teeth and reduction of damage caused by bruxism, not for diagnosing a condition.
No
The device description clearly states it is a physical mouthguard made of a polymer, and the performance studies focus on its physical properties. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect teeth and reduce damage caused by bruxism or nighttime grinding. This is a physical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical mouthguard that is heated and molded to the teeth. It's a physical barrier and protective device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on physical properties (tensile strength, hardness, etc.) and biocompatibility, which are relevant to a physical device used in the mouth, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This mouthguard does not fit that description.
N/A
Intended Use / Indications for Use
The Akervall Technologies mouthguards (ProTech Dent.) are indicated for use in protecting the teeth and reduce damage caused by bruxism or nighttime grinding.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
The ProTech Dent guard consists of a polycaprolactone based polymer with a tensile strength significantly higher than EVA( 29.11 MPa versus 22.3 MPa). It comes in a pre-shaped form (1.6 mm thick). The form softens when heated in hot water and can then easily be custom fit to the user's teeth. When the user sucks on the mouth guard it shapes around the teeth with no or minimal space between the material and the teeth. The polymer hardens in about 30 seconds and is then durable so that it does not deform when impacted with forces typically encountered in the mouth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter use
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)
The physical properties of the ProTech Dent mouthguard were tested and compared to the Den Tek Comfort Fit mouthguard. The hardness properties per the ASTM test showed the Pro Tech Dent shore comparable to the Den Tek Comfort Fit. However, the tensile strength of the Pro Tech Dent was 3.5 times greater than the Den Tek product. The tensile elongation of the Pro Tech Dent was 1.5 more than the Den Tek product. Also, the Young's Modulus, Water Sorption, Water Solubility, was compared with the predicate device.
Biocompatibility Data: Cytoxicity, Irritation and Sensitization tests were performed on the Pro Tech Dent product.
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.
K 072147
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.
Not Found
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
EXHIBIT 2
Akervall Technologies LLC+ 5520 Stone Valley Dr. Ann Arbor, MI 48105 Phone: 800-444-0570 Fax: 248.737.0636 Contact: Stephen Shulman, July 12, 2012
510(k) Summary
-
- Identification of the Device: Proprietary-Trade Name: "ProTech Dent," Device Class: Unclassified (Pre Amendment) Classification Name: Mouthguard: OBR, Common/Usual Name: Mouthguard, Over-the-Counter
-
Equivalent legally marketed devices: OBR : K 072147 DenTek Comfort Fit NightGuard
-
Intended Use: The Akervall Technologies mouthguards (ProTech Dent.) are indicated for use in protecting the teeth and reduce damage caused by bruxism or nighttime grinding.
-
Description of the Devices: Features & Benefits:
The ProTech Dent guard consists of a polycaprolactone based polymer with a tensile strength significantly higher than EVA( 29.11 MPa versus 22.3 MPa). It comes in a pre-shaped form (1.6 mm thick). The form softens when heated in hot water and can then easily be custom fit to the user's teeth. When the user sucks on the mouth guard it shapes around the teeth with no or minimal space between the material and the teeth. The polymer hardens in about 30 seconds and is then durable so that it does not deform when impacted with forces typically encountered in the mouth.
- Technological Characteristics:
The overall shape and dimensions are identical with commercially available mouth guards. They both are composed of a thermoplastic resin. The products are heated in hot water and cooled briefly and then molded to fit the teeth. Thinner than commercially available mouth guards, ProTech Dent is 1.6 mm thick versus 4.0 mm thick for EVA. ProTech Dent is perforated allowing saliva flow, but stronger with regards to impact protection based on laboratory testing ( ProTech Dent 29.11 MPA versus EVA 22.3 MPa).
- Performance Data:
The physical properties of the ProTech Dent mouthguard were tested and compared to the Den Tek Comfort Fit mouthguard. The hardness properties per the ASTM test showed the Pro Tech Dent shore comparable to the Den Tek Comfort Fit. However, the tensile
R.L.R.R
OCT 15 2012
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strength of the Pro Tech Dent was 3.5 times greater than the Den Tek product. The tensile elongation of the Pro Tech Dent was 1.5 more than the Den Tek product. Also, the Young's Modulus, Water Sorption, Water Solubility, was compared with the predicate device.
Biocompatibility Data: Cytoxicity, Irritation and Sensitization tests were performed on the Pro Tech Dent product.
Design and Use of Device
| YES | NO | |
|---|---|---|
| Is the device intended for prescription use (21 CFR 801 Subpart D)? | x | |
| Is the device intended for over-the-counter use (21 CFR 807 Subpart C)? | x | |
| Does the device contain components derived from a tissue or other biologic source? | x | |
| Is the device provided sterile? | x | |
| Is the device intended for single use? | x | |
| Is the device a reprocessed single use device? | x | |
| If yes, does this device type require reprocessed validation data? | ||
| Does the device contain a drug? | x | |
| Does the device contain a biologic? | x | |
| Does the device use software? | x | |
| Does the submission include clinical information? | x | |
| Is the device implanted? | x |
5. Comparison to predicate device:
| Comparison Areas | DenTek Night Guard
K072147 | Akervall Technologies
ProTech Dent, |
|---------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Indications for use | Protection against bruxism and
grinding. Intended to reduce damage
to teeth. | Protection against bruxism
and grinding. Intended to
reduce damage to teeth. |
| Design | Adjustable preformed oral device | Adjustable preformed oral |
| Materials | Thermoplastic resin | Thermoplastic resin |
| Reusable | Yes, single patient | Yes, single patient |
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-
- Conclusion In all respects, the Akervall Technologies mouth guard is substantially equivalent in terms of design, material, chemical composition and performance to commercially available mouth guards that are legally marketed for this purpose.
t
- Conclusion In all respects, the Akervall Technologies mouth guard is substantially equivalent in terms of design, material, chemical composition and performance to commercially available mouth guards that are legally marketed for this purpose.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration® 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 5 2012
Akervall Technologies Incorporated
Ms. Sassa Akervall
President
5520 Stone Valley Drive
Ann Arbor, Michigan 48105
Re: K121272
Trade/Device Name: ProTech Dent Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: September 11, 2012 Received: September 11, 2012
Dear Ms. Akervall:
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. 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.
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Page 2- Ms. Akervall
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Arison V. Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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i) Indications for Use
510(k) Number K22272
Device Name: ProTech Dent,
Indications for Use:
The Akervall Technologies mouthguards (ProTech Dent,) are indicated for use in protecting the teeth and reduce damage caused by bruxism or nighttime grinding.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use_ ._ .
Over the Counter Use yes (Per 21 CFR 801.109)
Susan Pearson
.
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121272
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