(109 days)
Not Found
Not Found
No
The device descriptions focus on mechanical repositioning of the jaw and do not mention any computational or learning-based components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The devices are designed to treat medical conditions (snoring, mild to moderate obstructive sleep apnea) by repositioning the lower jaw, which qualifies them as therapeutic devices.
No.
The device descriptions and intended uses clearly state that these devices are for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw, which is a therapeutic function, not a diagnostic one. They are designed to treat a condition, not to identify or assess it.
No
The device description clearly details physical, mechanical components (upper and lower arch systems, telescoping tubes and rods, pressure-formed splints, orthodontic acrylic) which are hardware, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described devices (Removable Acrylic Herbst, Allesee Snore Appliance, Enoch Snorinator) are all physical appliances designed to be worn in the mouth to reposition the lower jaw. They directly interact with the patient's anatomy to achieve a therapeutic effect (reducing snoring and sleep apnea).
- Lack of Sample Analysis: There is no mention of these devices analyzing any biological samples or performing any diagnostic tests on samples taken from the patient. Their function is purely mechanical and therapeutic.
The devices described are medical devices, specifically dental appliances, used for the treatment of snoring and mild to moderate obstructive sleep apnea. They fall under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Enoch Snorinator is intended to be used for the reduction of snoring and mild to modcrate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Removable Acrylic Herbst appliance is an upper and lower arch system designed to hold the lower jaw forward which increases the lower airway passage and reduces the tendency to snore. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) Herbst mechanism. The system bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The degree to which the patient's lower jaw is supported in an anterior position is determined by the dentist.
The Enoch Snorinator is a one-piece appliance designed for the upper arch only. It is a pressureformed anterior repositioning splint which postures the lower jaw forward to alleviate snoring. The anterior portion is formed into a "ramp" shape to engage the lower incisors. This ramp postures the lower jaw into the prescribed position as determined by the dentist.
The Allesee Snore Appliance (ASA) is a one-piece upper and lower, pressure-formed splint. The upper and lower jaw plastic appliances are joined together with orthodontic acrylic. The appliance postures the patient's lower jaw in a forward or anterior position. The amount of advancement is patient specific and determined by the dentist. The appliance has a rectangular airway between the upper and lower anterior teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower jaw, upper jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist (for determination of advancement)
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)
Not Found
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.
State University of New York at Buffalo, School of Dental Medicine, Removable Herbst Appliance, Hays & Meade Inc., Snore Guard, Great Lakes Orthodontic Laboratory, NAPA Appliance
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
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
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.(b)
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.”
0
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a bold, sans-serif font. The word 'Submitter:' is printed below the company name.
MAY 2 5 2007
Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177
Contact: Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007
Device Name:
- Trade Name Removable Acrylic Herbst .
- . Common Name - Intraoral Device for Snoring and/or Sleep Apnea
- Classification Name Intraoral Device for Snoring and Intraoral Device for Snoring and � Obstructive Sleep Apnea, per 21 CFR § 872.5570
Devices for Which Substantial Equivalence is Claimed:
- State University of New York at Buffalo, School of Dental Medicine, Removable Herbst . Appliance
Device Description:
The Removable Acrylic Herbst appliance is an upper and lower arch system designed to hold the lower jaw forward which increases the lower airway passage and reduces the tendency to snore. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) Herbst mechanism. The system is bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The degree to which the patient's lower jaw is supported in an anterior position is determined by the dentist.
Intended Use of the Device:
The intended use of the Removable Acrylic Herbst is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.
Substantial Equivalence:
The Removable Acrylic Herbst is substantially equivalent to another legally marketed device in the United States. The Removable Acrylic Herbst is used in a manner similar to the Removable Herbst Appliance developed by the State University of NY at Buffalo, School of Dental Medicine.
1
K070327
Image /page/1/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, bold font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.
Submitter:
Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177
Contact:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007
Device Name:
- . Trade Name - Enoch Snorinator
- . Common Name - Intraoral Device for Snoring and/or Sleep Apnea
- . Classification Name - Intraoral Device for Snoring and Intraoral Device for Snoring and Obstructive Sleep Apnea, per 21 CFR § 872.5570
Devices for Which Substantial Equivalence is Claimed:
- . Hays & Meade Inc., Snore Guard
Device Description:
The Enoch Snorinator is a one-piece appliance designed for the upper arch only. It is a pressureformed anterior repositioning splint which postures the lower jaw forward to alleviate snoring. The anterior portion is formed into a "ramp" shape to engage the lower incisors. This ramp postures the lower jaw into the prescribed position as determined by the dentist.
Intended Use of the Device:
The intended use of the Enoch Snorinator is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.
Substantial Equivalence:
The Enoch Snorinator is substantially equivalent to another legally marketed device in the United States. The Enoch Snorinator is used in a manner similar to the Snore Guard appliance developed by Hays & Meade Inc.
1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400
2
070327
Image /page/2/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a bold, sans-serif font. The word 'Submitter:' is printed below the company name.
Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177
Contact:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007
Device Name:
- . Trade Name - Allesee Snore Appliance (ASA)
- . Common Name - Intraoral Device for Snoring and/or Sleep Apnea
- Classification Name Intraoral Device for Snoring and Intraoral Device for Snoring and ● Obstructive Sleep Apnea, per 21 CFR § 872.5570
Devices for Which Substantial Equivalence is Claimed:
- . Great Lakes Orthodontic Laboratory, NAPA Appliance
Device Description:
The Allesee Snore Appliance (ASA) is a one-piece upper and lower, pressure-formed splint. The upper and lower jaw plastic appliances are joined together with orthodontic acrylic. The appliance postures the patient's lower jaw in a forward or anterior position. The amount of advancement is patient specific and determined by the dentist. The appliance has a rectangular airway between the upper and lower anterior teeth.
Intended Use of the Device:
The intended use of the Allesee Snore Appliance (ASA) is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.
Substantial Equivalence:
The Allesee Snore Appliance (ASA) is substantially equivalent to another legally marketed device in the United States. The Allesee Snore Appliance (ASA) is used in a manner similar to the NAPA Appliance produced by Great Lakes Orthodontic Laboratory.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus-like symbol, with three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
MAY 2 5 2007
Re: K070327
Trade/Device Name: Removable Acrylic Herbst, Allesee Snore Appliance (ASA), and Enoch Snorinator Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: May 11, 2007 Received: May 14, 2007
Dear Ms. Boswell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Ms. Boswell
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suyite y. Michie Omp.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K070327
Indications for Use
510(k) Number (if known): K070327
Device Name: Removable Acrylic Herbst
Indications for Use:
The Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBer DOS for Dr. Susan Runner
ospital
6
Indications for Use
510(k) Number (if known): K070327
Device Name: Allesee Snore Appliance (ASA)
Indications for Use:
The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
× Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Betz DDS for Dr Susan Runner
Hospital
7
70327
Indications for Use
510(k) Number (if known): K070327
Device Name: Enoch Snorinator
Indications for Use:
The Enoch Snorinator is intended to be used for the reduction of snoring and mild to modcrate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Betz DDS for Dr. Susan Rummer
Hospital
310(k): K070327