Device Description : CHEMFIL ROCK INTRO KIT is a high-strength zinc-reinforced glass ionomer restorat CHEMFIL ROCK INTRO KIT is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting. The capsule extruder is used for the extrusion and direct application of the capsules. With its supporting accessory (Capsule Extruder) it can be classified as a convenience kit.
Device Class : 2
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CHEMFIL ROCK A1 REFILL is a high-strength zinc-reinforced glass ionomer restorat CHEMFIL ROCK A1 REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.
Device Class :
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CHEMFIL ROCK A2 REFILL is a high-strength zinc-reinforced glass ionomer restorat CHEMFIL ROCK A2 REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.
Device Class :
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CHEMFIL ROCK A3 REFILL is a high-strength zinc-reinforced glass ionomer restorat CHEMFIL ROCK A3 REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.
Device Class :
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CHEMFIL ROCK A4-O REFILL is a high-strength zinc-reinforced glass ionomer restor CHEMFIL ROCK A4-O REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.
Device Class :
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CHEMFIL ROCK CONTRAST WHITE is a high-strength zinc-reinforced glass ionomer res CHEMFIL ROCK CONTRAST WHITE is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.
Device Class :
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Capsule Extruder 2 is the device designed for extrusion and direct application o Capsule Extruder 2 is the device designed for extrusion and direct application ofChemFil® Rock restorative capsules
Device Class : 1
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : AH 26 SILVERFREE RESIN Refill is a refill item of the 2 component powder/resin r AH 26 SILVERFREE RESIN Refill is a refill item of the 2 component powder/resin root canal filling material containing a resin tube (D010K3019120).
Device Class : 2
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : AH 26 Refill is a 2 component powder/resin root canal filling material consisti AH 26 Refill is a 2 component powder/resin root canal filling material consisting of a powder jar (D010K3019010) and a resin tube (D010K3019120)
Device Class :
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : AH Plus Refill Kit is a two-component paste/paste root canal sealer based on epo AH Plus Refill Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B (D010K3018020 and D010K3018030). With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Device Class : 2
Duns Number: 315471722
Premarket Exempt : Yes
Prescription Use : Yes