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EIS — Remover, Crown Class I

FDA Device Classification

FDA product code EIS covers "Remover, Crown", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 19 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EIS
Device Class
Class I
Regulation Number
872.4565
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K992649j. morita usaATD AUTOMATIC BRIDGE REMOVEROctober 29, 1999
K951299dentcoEASY PNEUMATIC CROWN AND BRIDGE REMOVERAugust 29, 1995
K863500pacific union dentalSTAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CARSeptember 22, 1986
K854795fran hazeltonHAZELTON TEMPORARY CROWN AND BRIDGE REMOVERMarch 4, 1986
K842026higa manufacturingH-TYPE BRIDGE REMOVERJuly 11, 1984
K833290genesis industriesC & B 40 PENTRO C & B40January 3, 1984
K833287genesis industriesSATIN CAST ECONOCASTJanuary 3, 1984
K833289genesis industriesC & B 61 PENTRON C & B61December 29, 1983
K833736jeneric indGOLD-PALLADIUM-SILVER BASED CAST/ALLOYDecember 29, 1983
K833278genesis industriesC & B 45December 29, 1983
K833280genesis industriesSUPRA AP CHOICE 83December 26, 1983
K833285genesis industriesRX IV PENTRON IVDecember 22, 1983
K833288genesis industriesC & B57 PENTRON C & B57December 20, 1983
K833282genesis industriesRX NYSP PENTRON 60November 28, 1983
K833284genesis industriesRX 41 PENTRON 41November 28, 1983
K833281genesis industriesRX D PENTRONNovember 28, 1983
K833286genesis industriesRX SEG ECONOPLUSNovember 28, 1983
K833283genesis industriesRX ORY PENTRON C & BNovember 28, 1983
K833279genesis industriesNATURELLE-LITENovember 28, 1983

FDA data resources