Search Results
Found 1 results
510(k) Data Aggregation
K Number
K021121Device Name
AROMACRYL
Manufacturer
Date Cleared
2002-05-28
(50 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
AROMACRYL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Aromacryl's relining, repairing/rebasing resin is indicated for the fabrication of flavored/fragranced orthodontic appliances.
Device Description
The Aromacryl device is an orthodontic appliance using industry standard stainless steel wire and Aromacryl polymer and monomer. Aromacryl can be used to fabricate devices, such as orthopedic and functional appliances to correct malocclusions or post-treatment retention devices known as hawley retainers. The Aromacryl product offers the patient a pleasant tasting appliance by the addition of FDA approved food grade flavoring that is GRAS (Generally Recognized As Safe) for this application.
Ask a Question
Ask a specific question about this device
Page 1 of 1