Product Code: EIS


Products Classified as EIS

1191Remover, CrownDental Hand Instrument.

Total Product Life Cycle (TPLC) Devices

1191Remover, CrownDental Hand Instrument.

FDA Consensus Standards

Remover, Crown [34709]21 CFR §872.4565 🔎
Remover, Crown [32013]21 CFR §872.4565 🔎

Pre-market Notifications for EIS

K992649ATD AUTOMATIC BRIDGE REMOVERJ. MORITA USA, INC.
K951299EASY PNEUMATIC CROWN AND BRIDGE REMOVERDENTCO, INC.
K863500STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CARPACIFIC UNION DENTAL, INC.
K854795HAZELTON TEMPORARY CROWN AND BRIDGE REMOVERFRAN HAZELTON CO.
K842026H-TYPE BRIDGE REMOVERHIGA MANUFACTURING LTD.
K833736GOLD-PALLADIUM-SILVER BASED CAST/ALLOYJENERIC IND.
K833278C & B 45GENESIS INDUSTRIES, INC.
K833289C & B 61 PENTRON C & B61GENESIS INDUSTRIES, INC.
K833279NATURELLE-LITEGENESIS INDUSTRIES, INC.
K833284RX 41 PENTRON 41GENESIS INDUSTRIES, INC.
K833281RX D PENTRONGENESIS INDUSTRIES, INC.
K833282RX NYSP PENTRON 60GENESIS INDUSTRIES, INC.
K833283RX ORY PENTRON C & BGENESIS INDUSTRIES, INC.
K833286RX SEG ECONOPLUSGENESIS INDUSTRIES, INC.
K833290C & B 40 PENTRO C & B40GENESIS INDUSTRIES, INC.

Global Unique Device Identification Database

00366975022936Remover, Crown
00366975018922Remover, Crown
00817524023350Remover, Crown
00817524023343Remover, Crown
H834KK900REMOVER, CROWN
H8347220REMOVER, CROWN
H834724C0REMOVER, CROWN
H834724B0REMOVER, CROWN
H834724A0REMOVER, CROWN
H8347210TC0REMOVER, CROWN
H834KK450REMOVER, CROWN
H834KK0REMOVER, CROWN
D8379911500Remover, Crown
D8379910370Remover, Crown
D8379910360Remover, Crown

Maude Adverse Events

PRIMARY CROWN CRIMPERINTEGRA LIFESCIENCES CORPORATION2018-06-21
WYNMAN CARB CROWN GRIPPERG. HIPP & SON2016-11-10
WYNMAN CARB CROWN GRIPPERINTEGRA YORK, PA INC.2016-10-14
WYNMAN CARB CROWN GRIPPERINTEGRA YORK, PA INC.2016-09-14
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