DR GREENBURGS HYBRID ACRYLIC

{0}------------------------------------------------ K/20.371 Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 igreenburg@earthlink.net JUN 2 7 2012 ## 510(k) SUMMARY Summary Prepared on 2-3-2012 Contact Person: Jonathan Greenburg DDS President Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 4144817 jgreenburg@earthlink.net Name of Device: Dr Greenburgs Hybrid Acrylic Common or Usual Name: Anti-Snoring and Apnea Device Classification Name: Anti-Snoring Device (21CFR872.5570) Product Code: LRK ### Predicate Devices: Dr Greenburgs Hybrid (K111680) SomnoGuard (K061688) Respire Blue Series (K11207) Full Breath (K091035) Silent Nite (K972424) EMA (K971794) {1}------------------------------------------------ Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 . 818 414 4817 igreenburg@earthlink.net # Description of the Device: The Dr Greenburgs Hybrid Assoc. The Dr Greenburgs Hybrid Acrylic Anti-Snoring Device is a removable intracted device for repositioning the upper and lower jaw into a prescribed relationship for a single an resure in Creatiourgs Hybrid Anti-Snoring Device is a removable intraoral device for muliple times at home or sleep laboratories. and theming the upper and lower jaw into and one multiple times at home or sleep laboratories. The Dr Greenburgs Hybrid Azalea The Dr Greenburgs Hybrid Acrylin States. includes an additional elastic struction in the piece, upper and lover andem to use airway. The tray system is component which imp ind in Streamditional elastic component which impectes uper and tower arch tray system th includes an additional elastic component which impedes the tongee final into the keo ar hate an additional elastic opening and lover and lover arch tray system that airway. The tray system is a more the market becar and the back into her into her into her i the inter to increase the also whiles impedes the follows than alling back they book in the intent back back in and the may shoren than should one in only in the intent and i on alles to mercease the airway passage opening, while the addits servive back into the times back into the time the nective post into the comments. The combined effect of th The combined effect of the advancement of the lower jaw, and the eard be may be and be from falling back into the airway reduces snoring and the target of the torgree apnea. from something back into the airway reduces snoring and the elastic impeding the airway. Them the airway reduces snoring and breathing arrests due to obstructive sleep ing and breathing arrests due to obstructive sleep Dr Greenburgs Hybrid Acrylic has a front area opening that is large enough for emergency s war is large enough for emer Dr Greenburgs Hybrid Acrylic Shoring appliance consists of two is areagnor morgency of FDA approved, well known and between the trays located posterly. The Bor 250mm 35 Hyrid Acrylic Storing appliance consists of two independent trays (Top and of From), and at elatis comected between the trays located posterior. The trays cons of For and eastic that is comments of the independent trays (Top and of FD) approved, well known andersed betrops located posterior. The trassis the gives stretur and support a sa strength and strater and longtine used onl material Ped posterior The Uner on Thop and The gires on The gires on The energer of the energer comments and corplates free. silicone. The dastic stromator and material posists of a material per Prosidions (richers). A brergy sorgir de trays consisted. stilicone. The elastic stromonolato de any to in the tongue from fallinom molar o molar o molar across the tone moredacty late Alpiedio, Mormodo do Moredo, Mormodo dio Moredo, Morano, Moremento, Alpes provence al prov ato the tongue from falling in swalling airway. The flexible of the stight of the stress the aller aller aller aller aller aller aller aller aller aller aller aller alle all of the rongue, aiding in swallowing and comfort. The flew of the field proves sight proves sight proves sight provent any tones slight provent any tonestions of the bottoms securing buttons and is locked securely between is held firm. The top tray be Unto the bottom tray via Securely between the two trays. The top tray ho y has a telescopic advance mechanis activated to it. The top tray has a telescopic advances) conanism the are are mom tray via activated to its most therape moniments on the that moves forward when protuding dorsal side wings activated to its most theraped and setting. The botton side that moves forward when activated to its most the more the unsy works in syncery with the top tray via forward s article to its most therapeution on is posterior side that moves forward when when protruding dorsal side wings the upper tray morks in synergy with the born and forward t {2}------------------------------------------------ ## Always More Marketing Inc . 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 igreenburg@earthlink.net Indications for Use: Dr Greenburgs Hybrid Anti-Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of Snoring and/or mild to modersts in a seat as a for Ose: Dr Greenburgs Hybrid Acrylic Arti-Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or midd T echnological Characteristics: Dr Greenburgs Hybrid Acrylic device has the foilacing similarities to the previously cleared predicate devices: S similarities to the previously cleared predicate devices: Same intended use. Same operating principle. Same technology. Same manufacturing process. ings process. All of the predicates and Dr Greenburgs Hybrid Acrylic act as mandibular repositioners for the treatment of snoring and mild to moderate Obstructive Sleep Apnea treatment of snoring and Dr Greenburgs Hybrid Acrylic act as mands. It Greenburgs Hybrid to moderate Obstructive Sleep Apnea. Dr Greenburgs Hybrid Acrylic, the Full Breath (R091035), and Dr Greenburgs Hybrid Dr. C the consurgs Hybrid Acrylic, the Full Breath (K. (K111680) all have tongue retaining components. Dr. Greenburgs Hybrid Acrylic, the SJA Dr Greenburgs Hybrid Acrylic, the Silent Nite (K972424), EMA (K971794) and Dr Greenburgs Substantist F Hybrid (K111680) use straps/bands held onto button attachments. Substantial East of the Silent Sheld onto button attachments. Substantial Equivalence is based on non-clinical data. In addition the literature sp In addition the literature supports the historical as a comi devices that reposition the Jaw and reduce and manage snoring as well as sleep apnea. jaw and reduce and manage snoring as well as sleep appear The Abstract Oral Appliances for Snoring The Abstract Oral Appliances for Snoring and Observe Steep Apnea: A Reviews and Check Charact Crail States chance of being able to control their sheep announce with mild to s Vol. 2006: Oral Appliances for Snoring and Obstructive Sleep Apne: : A Review from SLE Vol. 2, 2006 Page 259 states... "Overall, hose with mild to severe OSA have a 22% wh chance of being able to control their sit of the sever Apres: A Review from SLEB effice of being able to control the severe on and miller severe OSA bare and one of server of e for that CPAP but may be better apprea using and midd o severe OSA Of Arcal Soles Of Sol Sol Sol Sol Sol Sol Sol Sol Sol Sol Soles are are assul CP Ar out may be better patients than nasal CP ar on stars and on and on the marker of the worders subjects used both treatments." Also, "They are well toles w lite and would theatments." Also, "They are well tolemed by most patients" and "Mort less literate now provides evidence for the efficacy of OAs in the trabilished to moderate OSA " Based on clinical data it Based on clinical data, it is demonstrated in a variety of articles that looked at oral applian minutation means by which these conditions can be no and the windi data, it is demonstrated in a variety of atticles that looked at oral appliances and their use for the treatment of shoring and sloep and appliance therapy is a ment as as of the treatment of sacks bat looks, or alceles that hoked at oral appliances means by which these conditions can be managed. This effective the wasy which these conditions can be managed. of aspects including safety, convenience and cost. Clinical data provided (Jonathan Greenburg's Sleep Study Table) illustrates patients ean invalve their sleep apnea disease significantly if they use an intraoral anti-snorin n and aska provided (Johathan Greenburg's Sleep Study Table) illustrates patients can improve their sleep apnea disease significantly if they use an intraoral anti-snoring d {3}------------------------------------------------ Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 igreenburg@earthlink.net A risk assessment concluded that there were no new safety concerns raised by the design of Dr Greenburgs Hybrid Acrylic. In conclusion, a number of studies have shown improvement of the airway during sleep utilizing imaging associated with the use of oral appliances (also referred to as Oral Airway Dilators), aid in the management and reduction of snoring and sleep apnea. In addition the clinical data that was provided (Jonathan Greenburg's Sleep Study Table) illustrates patients can improve their sleep apnea disease significantly if they use an intraoral anti-snoring device with a tongue retaining component during sleep. In summary, the device described in this submission is substantially equivalent to the predicate devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is simple and recognizable, conveying the department's role in public health and welfare. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ### JUN 2 7 2012 Jonathan Greenburg, DDS President Always More Marketing, Incorporated 4535 West Sahara Avenue. Suite 200 Las Vegas, Nevada 89102 Re: K120371 Trade/Device Name: Dr Greenburgs Hybrid Acrylic 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 29, 2012 Received: June 5, 2012 Dear Dr. Greenburg: . 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 - Dr. Greenburg 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 ### Enclosure {6}------------------------------------------------ K120371. ## Indications for Use 510(k) Number (if known): Device Name: Dr Greenburgs Hybrid Acrylic Indications For Use: The Dr Greenburgs Hybrid Acrylic Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate # obstructive sleep apnea Prescription Use (Part 21 CFR 801 Subpart D) [check mark] AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Daver (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 510(k) Number: