Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

Therm-o-Flex®

FDA UDI

Dentsply International Inc.·D001N4061340·Acetal Resin

N.A.

FDA UDI

DENTAURUM GmbH & Co.KG·J011320002000·Cuspids with rest, teeth 23, 43, 0.90 mm / 36

LEONE SPA

FDA UDI

LEONE SPA·08033707002970·BALL HOOKS 0,9mm

LEONE SPA

FDA UDI

LEONE SPA·08033707090137·REVERSE PALATAL BARS - 48mm

Zirlux

FDA UDI

HENRY SCHEIN, INC.·00304040110980·Zirlux Acetal LTD A2 98x22MM

LEONE SPA

FDA UDI

LEONE SPA·08033707002697·ADAMS CLASP STANDARD KIT

remanium®

FDA UDI

DENTAURUM GmbH & Co.KG·J011620109000·remanium® ball retainer clasps, ø 0.90 mm

Zirlux

FDA UDI

HENRY SCHEIN, INC.·00304040023419·ZIRLUX ACETAL MILLING DISC

Therm-o-Flex®

FDA UDI

Dentsply International Inc.·D001N4061470·Acetal Resin

Keystone Industries

FDA UDI

Keystone Industries·H66812713001·#9 Pre-Formed Clasp Pkg 100

LEONE SPA

FDA UDI

LEONE SPA·08033707002659·ADAMS CLASPS STANDARD 9,0mm

Therm-o-Flex®

FDA UDI

Dentsply International Inc.·D001N4061600·Acetal Resin

LEONE SPA

FDA UDI

LEONE SPA·08033707002468·PALATAL BARS - 52mm

LEONE SPA

FDA UDI

LEONE SPA·08033707002611·ADAMS CLASPS STANDARD 6,0mm

LEONE SPA

FDA UDI

LEONE SPA·08033707090014·PALATAL BARS - 44mm

LEONE SPA

FDA UDI

LEONE SPA·08033707090151·REVERSE PALATAL BARS - 52mm

LEONE SPA

FDA UDI

LEONE SPA·08033707002635·ADAMS CLASPS STANDARD 7,0mm

LEONE SPA

FDA UDI

LEONE SPA·08033707002406·PALATAL BARS - 40mm .

LEONE SPA

FDA UDI

LEONE SPA·08033707068051·LIP BUMPER 045 WITH LOOPS/STOP n. 1