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510(k) Data Aggregation
K Number
K112868Device Name
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
Manufacturer
Date Cleared
2012-01-19
(111 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DREAMGARD, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dreamgard nightguards are indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle. Dreamgard nightguards are for prescription use only.
Device Description
The Dreamgard REM-SOFT, REM-LITE, REM-ULTRA and REM-MAX nightguards are composed of a soft, clear material made of thermoplastic resins. The devices are custom fabricated for each patient by taking an impression of the patient's upper teeth and using that impression to create a dental model to then fabricate a multi-layer custom nightguard using a pressure thermo-forming machine. The nightguard is designed to fit on the upper teeth and to span from 2nd molar to 2nd molar. The four versions of the Dreamgard nightguards differ in thickness based on the number of layers of thermoplastic resin used. The final custom product has a soft, comfortable inner layer and a harder protective outer layer. The dentist delivers the nightguard to the patient and provides final fitting and bite balancing adjustments by using the "boil and bite" method to mold the fit to the patient's teeth and bite.
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