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EAX — Mirror, Mouth Class I

FDA Device Classification

FDA product code EAX covers "Mirror, Mouth", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 12 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EAX
Device Class
Class I
Regulation Number
872.4565
Submission Type
510(k) Exempt
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K946073Hines GroupORALVUE DENTAL MIRRORFeb 16, 1995
K935906Ranir/DcpRANIR PLAX RXSep 2, 1994
K941574Union Broach, Div. Moyco IndustriesRETRO MIRRORMay 18, 1994
K935687Dentalsafe Systems PtyNILFeb 3, 1994
K863766Medical GroupDISPOSABLE MOUTH MIRRORS, SINGLE USE ONLYOct 30, 1986
K863767Medical GroupGLASS MOUTH MIRRORS, REUSABLEOct 30, 1986
K833310HtiFOGCUTTER DENTAL MOUTH MIRRORMay 7, 1984
K841199Henry ScheinFIBERGLASS MOUTH MIRRORSApr 25, 1984
K833429DentecPERI MIRROR/SALIVA EJECTORDec 22, 1983
K830777Almore IntlELECTRIC MOUTH MIRRORApr 6, 1983
K821777Pacific DentalBEACH MOUTH MIRRORJul 6, 1982
K800919TeledyneORAVIEW BY WATER PIKMay 8, 1980

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.