DENTSPLY INTERNATIONAL INC. 648001 Esthet-X®flow Liquid Micro Hybrid

K-WIRE TROCAR POINT BOTH ENDS .062 X 4

Precision Reciprocating (22.5 x 0.64mm)

K-WIRE Trocar POINT BOTH ENDS .035 x 4

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Endodontic sealing material, 10mL Liquid

This is sold as part of the 11-Unit Packages for Lucitone 199 and Hy-Pro Lucitone. It is not sold separately.

This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.

2108 Series Sagittal Blade (28.9 x 0.64 x 58.7mm)

Precision Thin Offset (10.0 x 0.38 x 43.0mm)

X-Ray Detectable Sponge, Sterile, 4" x 4", 16-Ply, 10 per tray

K-WIRE TROCAR POINT BOTH ENDS .062 X 4

Precision Reciprocating (22.5 x 0.64mm)

K-WIRE Trocar POINT BOTH ENDS .035 x 4

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.