← Product Code OBR · K151149 # Ready-Fit (K151149) _Den Tek Oral Care, Inc. · OBR · Sep 30, 2015 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K151149 ## Device Facts - **Applicant:** Den Tek Oral Care, Inc. - **Product Code:** OBR - **Decision Date:** Sep 30, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Indications for Use 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. ## Device Story Ready-Fit Disposable Dental Guard is a posterior-only, ready-to-wear occlusive mouthguard; features two molar bite surfaces, each with three cylinders (bite tubes) connected by a buccal retention band. Device is worn by patients (age 18+) at home during sleep to manage bruxism. Patient places guard on upper or lower teeth; cylinders cushion teeth and maintain separation during grinding. Device is disposable after single-night use. Benefits include reduced tooth damage and protection against grinding-related wear. ## Clinical Evidence Bench testing only. Conducted in-home use test (IHUT) to validate design performance. Material testing included density (ASTM D792/ISO 1183), melt flow (ASTM D1238/ISO 1133), Shore Hardness A and D (ASTM 2240/ISO 868), tensile strength, elongation at break, and tensile modulus (ASTM 638/ISO 527-2). ## Technological Characteristics Posterior-only occlusive mouthguard; material: EMA; dimensions: 3.8cm x 3.9cm x 1.9cm; weight: 0.04 oz; non-sterile; single-use disposable. Standards: ASTM D792, ASTM D1238, ASTM 2240, ASTM 638. ## Regulatory Identification To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding. ## Predicate Devices - Grind No More ([K082301](/device/K082301.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 30, 2015 Den Tek Oral Care, Inc. Ms. Linda Giles Regulatory & Compliance Specialist 397 Excellence Way Maryville, Tennessee 37801 Re: K151149 Trade/Device Name: Ready-Fit Disposable Dental Guard Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: August 18, 2015 Received: August 21, 2015 #### Dear Ms. Giles: 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. {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 (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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use Statement Section 4: 510(k) Number (if known): K151149 Device Name: Ready-Fit Disposable Dental Guard ______________________________________________________________________________________________________________________________________________________________________________ # Indications for Use: 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. Prescription Use (Per 21 C.F.R. 801.109) AND/OR Over-The-Counter Use X (Per 21 C.F.R. 801 Subpart C) ______________________________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ______________________________________________________________________________________________________________________________________________________________________________ {3}------------------------------------------------ #### Traditional 510(k) SUMMARY - K151149 Section 5. ## DenTek Oral Care Inc.'s Ready-Fit Disposable Dental Guard ## 510(k) Owner's Name, Address, Phone and Fax Number DenTek Oral Care, Inc. 307 Excellence W av Maryville, TN 37801 Phone: (865) 983-1300; Fax: (865) 983-2444 ## Contact Person and Date Prepared Linda Giles - Regulatory and Compliance Specialist Date Prepared: 08/18/2015 revision 2 ## Subject Device Device Trade Name: Readv-Fit Disposable Dental Guard Device Common or Usual Name: dental quard, nightguard Classification Name: Mouthguard, Over-the-Counter Product Code and Class: OBR; unclassified #### Predicate Device Trade Name: Grind No More Applicant: Placontrol Inc. Classification Name: Mouthguard, Over-the-Counter Product Code and Class: OBR; unclassified 510(k) Number: K082301 ## Device Description Ready-Fit Disposable Dental Guard is a ready-to-wear, posterior-only occlusive mouthquard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band. ## Indications for Use/Intended Use 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. {4}------------------------------------------------ # Sec. 5 - 510(k) Summarv K151149 (cont.) # Technological Characteristics Ready-Fit Disposable Dental Guard is a posterior-only occlusive mouthquard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band. Similarly the predicate device is a posterior-only occlusive mouthquard, consisting of two molar bite plates connected by a buccal retention band. The cylinders which make up the bite surfaces of the subject device allow the user to engage the quard in the natural anatomy of the teeth, and are substantially equivalent to the predicate device's bite pads, as they serve the same purpose - to cushion the teeth and keep them teeth apart during grinding. The technological/design differences between Ready-Fit Disposable Dental Guard and the predicate device, Grind No Mores, are minor and the subject device is, therefore, technologically similar to the predicate device. Both the subject device and the predicate device are indicated for over-the-counter use and are disposable after one night's use. # Substantial Equivalence # Substantial Equivalence Chart DenTek Ora I Care , Inc . ' s Re a d y-Fit Disposable Dental Guard -K151149 | | Ready-Fit Disposable
Dental Guard
(K151149) Subject Device | Grind No More
(K082301)
Predicate Device | Conclusion | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Indications for
Use | 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. | Grind No More 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
teeth grinding. | Equivalent | | User Population | OTC, age 18 and up | OTC, age 18 and up | Equivalent | | DESIGN | | | | | Technological
Characteristics | A posterior-occlusive
mouthguard, comprised of
two molar bite surfaces, each
with 3 cylinders (bite tubes),
connected by a buccal
retaining strap. | A posterior-occlusive
mouthguard, comprised of
two molar bite plates, each
with alignment grooves,
connected by a buccal
retaining strap. | Substantially
Equivalent1 | | Materials | Comprised completely of
EMA material | Comprised completely of
EMA material | Equivalent | | Fit | One Size Fits All, worn on
upper or lower teeth | One Size Fits All, worn on
upper or lower teeth | Equivalent | {5}------------------------------------------------ | Dimensions
(l x w x h) | 3.8cm L x 3.9cm W x 1.9cm H | 4.5cm L x 3.5cm W x 1.7cm H | Substantially
Equivalent2 | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------| | Weight | 0.04 ounce | 0.06 ounce | Substantially
Equivalent2 | | Sterilization | Device is not provided sterile. | Device is not provided sterile. | Equivalent | | Method of
Disinfection or
Cleaning | The device is meant to be
discarded after one night's
use. No instructions for
cleaning are included. | The device is meant to be
discarded after one night's
use. No instructions for
cleaning are included. | Equivalent | | Standards with
which Device
Complies | None specified for Product
Code OBR | None specified for Product
Code OBR | Equivalent | - 1. Design differences do not affect substantial equivalence as the technological characteristics of both devices serve the same purpose - to reduce damage to teeth by cushioning them and keeping them apart. - 2. The differences in the device dimensions and weight are very small and the devices have a similar overall shape, fit the mouth in a similar manner and have the same function to protect the teeth from the damage of night-time grinding. ## Bench Test Results DenTek conducted an in-home use test (IHUT) during the month of April 2015, to validate that the design of Ready-Fit Disposable Dental Guard meets the intended use and performance of the device. Physical properties testing for density (ASTM D792 -ISO 1183) and melt flow (ASTM D1238 - ISO 1133) have been conducted on the material of the guard, and mechanical properties tests for Shore Hardness A and D (ASTM 2240 - ISO 868), tensile strength and elongation at break and the tensile modulus (ASTM 638 – ISO 527-2) of the material have also been tested. ## Conclusion Ready-Fit Disposable Dental Guard is substantially equivalent to the identified predicate device, Grind No More. Ready-Fit Disposable Dental Guard has the same intended uses, similar indications for use, technological characteristics, principles of operation, and has the same material composition as the predicate device. --- **Source:** [https://fda.innolitics.com/device/K151149](https://fda.innolitics.com/device/K151149) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com