(230 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a thermoplastic mouthguard, with no mention of AI or ML technologies.
Yes.
The device is used to mitigate the effects of bruxism (teeth clenching and grinding), which is a medical condition. It protects against damage to teeth and reduces associated noise.
No
Explanation: The device is an "Over-the-Counter dental guard indicated for the protection against bruxism," which is a protective and preventative function, not a diagnostic one. It does not analyze symptoms, identify conditions, or provide information about a patient's health status.
No
The device description explicitly states it is a mouthguard constructed of a propylene-based elastomer, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- This Device's Function: The Oral B plus Scope Outlast Nighttime Dental Guard is a physical device worn in the mouth to protect against the physical effects of bruxism (teeth grinding and clenching). It does not analyze any biological specimens or provide diagnostic information.
- Intended Use: The intended use is to reduce damage to teeth and prevent noise associated with teeth grinding, which are physical effects, not diagnostic purposes.
- Device Description: The description focuses on the physical construction and how it is molded and worn.
- Performance Studies: The performance studies mentioned are biocompatibility tests, which assess the safety of the material in contact with the body, not the diagnostic accuracy of the device.
Therefore, based on the provided information, this device clearly falls outside the definition and function of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.
Product codes
OBR
Device Description
a mouthguard constructed of a propylene-based elastomer. The target area is the oral cavity of individuals that suffer from bruxism, nighttime teeth grinding.
The device works by molding the thermoplastic resin to the individual's mouth. The thermoplastic resin can be molded after submerged in boiling water via the microwave. The molded thermoplastic resin is worn at night to reduce damage to the teeth and to prevent the noise associated teeth grinding.
OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard is intended for individuals age 18 and older. Thermoplastic can be molded to fit all sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
18 and older
Intended User / Care Setting
Over-the-Counter
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)
OraLabs relied on Biocompatibility testing as the basis for non-clinical data. The testing performed indicates the dental guard is safe for individuals to use.
The biocompatibility testing performed on the OraLabs Oral B plus Scope Outlast Nighttime Dental Guard included the tests listed below:
- MEM Elution Using L-929 Mouse Fibroblast Cells (ISO) (Cytotoxicity)
- Guinea Pig Maximization Sensitization Test (ISO) (Method for Biomaterial Extracts) - Per Extract
- Intracutaneous Irritation Test (ISO) (3 Rabbits) Per Extract
- Acute Systemic Injection Test (ISO) Per Extract
- SubChronic (14-day) Intravenous Toxicity Study in Non-Swiss Webster Mice (14 Repeat Dose Exposure) (includes hematology & clinical chemistry) (GLP)
The biocompatibility testing objectively concludes that the OraLabs Oral B plus Scope Outlast Nighttime Dental Guard is safe for consumers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows a logo for "OraLabs". The text is in a bold, sans-serif font and is surrounded by a thick, black border. The logo appears to be a vintage design, possibly from an older advertisement or product label.
510(k) Summary
JUN 2 7 2012
-
- Purpose of the 510(k) Notice OraLabs requests this 510(k) as it is a new device.
-
- Submitter's Information Name, Address, Telephone Number, Contact Person and Date Prepared
OraLabs, Inc. Gary Schlatter, CEO 18685 East Plaza Drive Parker, CO 80134 Phone:(303) 783-9499, Extension 3202 Fax: (303) 783-5759 www.oralabs.com
This summary was amended on 06/21/12 and any questions shall be addressed to:
Teresa Purdue Quality Assurance Director 18685 East Plaza Drive Parker, CO 80134 Phone:(303) 783-9499, Extension 3249 Fax: (303) 783-5759 www.oralabs.com
-
- Device Name
:
- Device Name
·
- Proprietary name - Oral-B plus Scope Outlast Nighttime Dental Guard
- Common Name of Device Dental Guard (Over-the-Counter) .
- . Classification Name - Unclassified
- t Classification Product Code - OBR
- . Review Panel - Dental
To my knowledge FDA has not classified this device.
-
- Devices to Which Substantial Equivalence is Claimed:
OraLabs claims equivalence to Dentek's Custom Comfort Dental Guard, 510(k) Number K083400.
- Devices to Which Substantial Equivalence is Claimed:
Dentek Oral Care, Inc. 307 Excellence Way Maryville, TN 37801
Section 5 Page 5.1
1
Image /page/1/Picture/0 description: The image shows the word "Oralabs" in a stylized font. The word is contained within a rectangular box with a decorative border. The letters are bold and outlined, giving them a three-dimensional appearance. The overall design has a vintage or retro feel.
Phone: (865) 983-1300 Facsimile: (865) 983-2444 Registration Number: 2938386 Product Code: OBR
5. Device Description
Description of device - a mouthguard constructed of a propylene-based elastomer. The target area is the oral cavity of individuals that suffer from bruxism, nighttime teeth grinding.
The device works by molding the thermoplastic resin to the individual's mouth. The thermoplastic resin can be molded after submerged in boiling water via the microwave. The molded thermoplastic resin is worn at to reduce damage to the teeth and to prevent the noise associated teeth grinding.
OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard is intended for individuals age 18 and older. Thermoplastic can be molded to fit all sizes.
Technology
The Oral B Nighttime Dental Guard plus Scope Outlast and the predicate device rely on the same technology for performance.
Physical State
The dental mouthguard in its physical state is composed of the following ingredients:
- Propylene-based elastomer B
- 제 Flavor
This presents a soft propylene-based elastomer that is molded to the individual's teeth.
Technical Method
The dental mouthguard is a removable appliance that is fitted to the teeth by taking an impression of the teeth when in a heated state.
Scientific Concepts
The OraLabs Oral B plus Scope Outlast Nighttime Dental Guard is based on the scientific concept of a physical barrier placed between the individual's teeth while they sleep. The barrier is intended to reduce damage to the teeth as the upper and lower teeth contact each other. In addition, the physical barrier is intended to reduce the noise associated with bruxing or grinding.
6. Technological Characteristics
OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard and the predicate device share the same scientific concept, a physical barrier placed between the upper
Section 5 Page 5, 2
2
Image /page/2/Picture/0 description: The image shows the logo for Oralabs. The logo is in a rectangular box with a black background and white text. The text is in a sans-serif font and is stacked on top of each other.
and lower teeth. Both devices use a soft, formable material that, when heated, fits to the individual's teeth.
OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard uses a propylene based elastomer.
OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard incorporates flavor with the nighttime dental guard. It does not change the functional characteristics in any way.
The OraLabs Oral B plus Scope Outlast Nighttime Dental Guard has passed biocompatibility testing listed for a medical device. As such, it is safe for an individual to use for a prolonged amount of time.
7. Performance Data:
- ISO 10993-12:2007 Biological Evaluation of Medical Devices, Part 12: . Sample Preparation and Reference Materials
- ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests . for In Vitro Cytotoxicity
- ISO 10993-10: 2010 Standard, Biological Evaluation of Medical Devices, . Part 10: Test for Irritation and Skin Sensitization, Pages 11-14, Pages 18-ટ્ટેલ
- ISO 10993-11: 2006 Biological Evaluation of Medical Devices Part 11: . Tests for Systemic Toxicity
8. Comparison Statements
OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard has the addition of flavor to the propylene-based elastomer. This allows the individual wearing the device to have a mint-flavored sensation upon use.
The addition of flavor does not change the physical barrier characteristics from the predicate device, Dentek's Custom Comfort Dental Guard.
Our device provides a physical barrier and is effective, safe, and substantially equivalent for use by individuals that experience night time teeth grinding.
A comparison table is included as an attachment to this section.
9. Non-Clinical Data
OraLabs relied on Biocompatibility testing as the basis for non-clinical data. The testing performed indicates the dental guard is safe for individuals to use.
Section 5 Page 5.3
3
OraLabs
The biocompatibility testing performed on the OraLabs Oral B plus Scope Quilast Nighttime Dental Guard included the tests listed below:
- MEM Elution Using L-929 Mouse Fibroblast Cells (ISO) (Cytotoxicity) .
- Guinea Pig Maximization Sensitization Test (ISO) (Method for . Biomaterial Extracts) - Per Extract
- Intracutaneous Irritation Test (ISO) (3 Rabbits) Per Extract ◆
- Acute Systemic Injection Test (ISO) Per Extract .
- . SubChronic (14-day) Intravenous Toxicity Study in Non-Swiss Webster Mice (14 Repeat Dose Exposure) (includes hematology & clinical chemistry) (GLP)
OraLabs researched literature for the symptoms and potential issues of "bruxism". Two sources we used were Stedmans Medical Dictionary and the Merck Manual. Research states that grinding can lead to jaw pain and other problems. A nighttime dental guard is a product that allows consumers to provide a barrier between their upper and lower teeth during periods in which they grind their teeth.
10. Indications for Use
:
. .
The Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.
11. Conclusion
The biocompatibility testing objectively concludes that the OraLabs Oral B plus Scope Outlast Nighttime Dental Guard is safe for consumers.
Dental guards have been used by several manufacturers to provide a protective barrier between the consumer's upper and lower teeth.
OraLabs Oral B plus Scope Outlast Nighttime Dental Guard has many of the same characteristics as the other devices, a soft, formable propylene-based elastomer that is fitted to individuals 18 years or older.
OraLabs Oral B plus Scope Outlast Nighttime Dental Guard is as safe and effective as the Dentek's Custom Comfort Dental Guard.
Section 5 Page 5.4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 7 2012
Ms. Teresa Purdue Quality Assurance Director Oralabs, Incorporated 18685 East Plaza Drive Parker, Colorado 80134
Re: K113326
Trade/Device Name: Oral B plus Scope Outlast Nighttime Dental Guard Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: OBR Dated: June 1, 2012 Received: June 4, 2012
Dear Ms. Teresa Purdue:
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.
5
Page 2 - Ms. Purdue
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,
ph for
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
6
Indications for Use Statement
13326
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name: Oral B plus Scope Outlast Nighttime Dental Guard
Indications for Use:
The Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated teeth grinding.
Prescription Use (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use X (Per 21 C.F.R. 807 Subpart C)
Susan Ryan
:Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K113326