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EFH — Paper, Articulation Class I

FDA Device Classification

FDA product code EFH covers "Paper, Articulation", a Class I medical device regulated under 21 CFR 872.6140. Submissions are reviewed by the Dental panel. At least 10 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EFH
Device Class
Class I
Regulation Number
872.6140
Submission Type
510(k) Exempt
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K965026Pfingst And CoPFINGST PRESSURE PASTEFeb 10, 1997
K912632Pascal CoOCCLUDEJan 17, 1992
K911259Pascal CoHYDENTJun 6, 1991
K864572Prodent IntlFIXTECTORFeb 12, 1987
K870032SentekREVISED T-SCAN SYSTEMFeb 2, 1987
K832647Ardent IntlARTICULATING PAPERFeb 21, 1984
K833132Myo-Tronics ResearchMUCOSAL ADJUSTMENT PASTE LIQUID SPRAYFeb 10, 1984
K810498Wallace A. Erickson AndCENTRIC (BITE) REGISTRATION PASTEMar 17, 1981
K771011Parker LaboratoriesARTICULATING PAPERJun 20, 1977
K770492Dey-MatCRACK DETECTOR, DEN-MATMar 21, 1977

FDA data resources

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