Snorbliss® Anti-Snoring Device
Device Facts
| Record ID | K261251 |
|---|---|
| Device Name | Snorbliss® Anti-Snoring Device |
| Applicant | Endeavor Commerce, LLC |
| Product Code | LRK · Dental |
| Decision Date | Jun 11, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5570 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Snorbliss® Anti-Snoring Device is intended to aid in the reduction of snoring.
Device Story
Snorbliss® Anti-Snoring Device is a custom-fitted, reusable intraoral device for home use. It consists of an upper brace, a lower brace, and an adjustment connecting strap. The device functions by mechanically repositioning the mandible anteriorly (up to 7 mm) to maintain an open airway, thereby improving airflow and reducing snoring sounds. It is intended for over-the-counter use by the patient to manage snoring.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Materials: Polypropylene (PP) and Ethylene vinyl acetate (EVA). Design: Custom-fitted, two-piece intraoral brace with adjustable connecting strap. Repositioning: Mandibular advancement up to 7 mm. Sterility: Non-sterile. Biocompatibility: ISO 10993. Mechanical standards: ASTM D790-17 (flexural strength/modulus), ASTM D638-22 (tensile strength/elongation), ASTM D570-22 (water absorption), ASTM D3418-21 (melting temperature), ASTM D792-20 (density).
Indications for Use
Indicated for adults seeking reduction of snoring. No specific contraindications provided.
Regulatory Classification
Identification
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.
Special Controls
*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Predicate Devices
- Difiney Anti Snoring Device (K233850)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 11, 2026
Endeavor Commerce, LLC
% Purity Chen
Manager
Shanghai Spica Management Consulting Co., Ltd.
609 Rm., #133 Shengang Ave., Pudong New District
Shanghai, 201306
China
Re: K261251
Trade/Device Name: Snorbliss® Anti-Snoring Device
Regulation Number: 21 CFR 872.5570
Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea
Regulatory Class: Class II
Product Code: LRK
Dated: April 15, 2026
Received: April 16, 2026
Dear Purity Chen:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261251 - Purity Chen
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K261251 - Purity Chen
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assistance/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,
FDA Bobak
Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K261251
Device Name
Snorbliss® Anti-Snoring Device
Indications for Use (Describe)
Snorbliss® Anti-Snoring Device is intended to aid in the reduction of snoring.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
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PSC Publishing Services (301) 443-6740 EF
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K261251
# Summary
## 1. Submitter Information
**Manufacturer Name:** Endeavor Commerce LLC
**Address:** 30 N Gould St Ste 47051 Sheridan, Wyoming 82801
**Tel:** +1 732 812 5665
**Email:** basaranhasem@gmail.com
**Contact Person:** HASEM BASARAN
## 2. Application correspondent
**Company Name:** Shanghai Spica Management Consulting Co., Ltd.
**Address:** 609 Room, No.133 Shengang Avenue, Pudong New District, Shanghai, China
**Tel:** 86-17802157742
**Email:** Purity@spicagloble.com
**Contact Person:** Purity Chen
## 3. Date prepared:
March 30, 2026
## 4. Device identification
| Trade Name | Snorbliss® Anti-Snoring Device |
| --- | --- |
| Model | Pro 2.0 |
| Regulation Number | 21 CFR 872.5570 |
| Regulation Name | Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea |
| Device Classification | Class II |
| Product Code | LRK |
| Panel | Dental |
## 5. Predicate device information
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# Summary
| Sponsor | FISSIONTECH LLC |
| --- | --- |
| Trade/Device Name | Difiney Anti Snoring Device |
| 510(K) number | K233850 |
| Regulation Number | 21 CFR 872.5570 |
### **6. Indications for use**
Snorbliss® Anti-Snoring Device is intended to aid in the reduction of snoring.
### **7. Device description**
The product consists of three parts. The first part is the upper brace, the second part is the lower brace, and the third part is the adjustment connecting strap. The materials used are PP and EVA. The upper brace and lower brace are made of PP and EVA respectively, while the connecting strap is made of PP.
### **8. Performance Testing - Clinical**
Not Applicable.
### **9. Performance Testing - Animal**
Not Applicable.
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# Summary
## Technological Characteristic Comparison
Provided below is a comparison of the subject device with the predicate device.
Table 16A: General Comparison
| Item | Subject Device | Predicate Device (K233850) | Comparison |
| --- | --- | --- | --- |
| Product Code | LRK | LRK | Same |
| Class | Class II | Class II | Same |
| Classification Name | Anti-Snoring Device | Anti-Snoring Device | Same |
| Proprietary Name | Snorbliss® Anti-Snoring Device | Difiney Anti Snoring Device | / |
| Technological Features | The Snorbliss® Anti - Snoring Device gently moves the lower jaw forward, helping to keep the airway open. This improves airflow, supports easier breathing, and reduces snoring sounds. | Difiney Anti Snoring Device helps reduce snoring by moving the lower jaw forward to open your airway to improve breathing allowing air to flow freely without the unhealthy and annoying sound of snoring. | Similar |
| Intended Use | Snorbliss® Anti-Snoring Device is intended to aid | The Difiney Anti Snoring device is intended to help reduce snoring in adults 18 years of age or | Similar |
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# Summary
| | in the reduction of snoring. | older. | |
| --- | --- | --- | --- |
| Materials | - Polypropylene - Ethylene vinyl acetate copolymer | - Polycarbonate resin - Ethylene vinyl acetate copolymer | Similar |
| Desirable Characteristics | Home use, heat sensitive / moldable, adjustable jaw advancement position | Home use, heat sensitive / moldable, adjustable jaw advancement position | Same |
| Specifications: - Physical: - Mechanical: - Single use: | - Custom-fitted intraoral device - Repositions mandible anteriorly up to 7 mm - Reusable | - Custom-fitted intraoral device - Repositions mandible anteriorly up to 4 mm - Reusable | Similar |
| Sterility | Non-sterile | Non-sterile | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
# **Summary of Non-Clinical Testing**
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
Biocompatibility test
Bio-compatibility assessment was conducted in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Physical properties
- ASTM D790-17 for flexural strength and flexural modulus.
- ASTM D638-22 for Tensile Strength and Elongation at break.
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# Summary
- ASTM D570-22 for water absorption.
- ASTM D3418-21 for melting temperature.
- ASTM D792-20 for Density.
# Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Snorbliss® Anti-Snoring Device is substantially equivalent to the legally marketed predicated device K233850.
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