EDGE ENDO LLC

Address:5600 Wyoming Blvd. NE Suite 100,Albuquerque,NM,87109,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cleanser, Root Canal (KJJ) (3) Scaler, Ultrasonic (ELC) (3) Resin, Root Canal Filling (KIF) (2) Crown And Bridge, Temporary, Resin (EBG) (1) Tester, Pulp (EAT) (1)

Premarket Exempt

No Yes

Clear

EdgeCaOH Calcium Hydroxide Root Canal Filling Material - 00818365020003 Catalog Number :

Device Description : For use, as a temporary root canal filling after endodontic surgery. Metapaste c

Device Class : 2

Duns Number: 078474365

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

EdgeSeal Root Canal Sealer - 00818365020010 Catalog Number :

Device Description : EdgeSeal is a biocompatible root canal sealer for permanent sealing of root cana

Device Class : 2

Duns Number: 078474365

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

EdgeTemp Hydraulic Temporary Restorative - 00818365020027 Catalog Number :

Device Description : For fabrication of temporary fillings and other temporary prosthetics for use un

Device Class : 2

Duns Number: 078474365

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

EdgeEndo Sodium Hypochloite - 00818365020034 Catalog Number :

Device Description : EdgeEndo sodium hypochlorite is a sodium hypochlorite solution in water with wet

Device Class : U

Duns Number: 078474365

Premarket Exempt : No

Product Code : KJJ

Prescription Use : Yes

Device Count : 1

EdgeEndo Chlohexidine - 00818365020041 Catalog Number :

Device Description : EdgeEndo Chlohexidine is a 2% Chlorhexidine Gluconate solution in water with sur

Device Class : U

Duns Number: 078474365

Premarket Exempt : No

Product Code : KJJ

Prescription Use : Yes

Device Count : 1

EDTA - 00818365020058 Catalog Number :

Device Description : EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tens

Device Class : U

Duns Number: 078474365

Premarket Exempt : No

Product Code : KJJ

Prescription Use : Yes

Device Count : 1

EdgeIce - 00818365020065 Catalog Number :

Device Description : EdgeIce Refrigerant pulp vitality spray is used in dentistry for the purpose of

Device Class : 2

Duns Number: 078474365

Premarket Exempt : Yes

Product Code : EAT

Prescription Use : Yes

Device Count : 1

EdgeSurgicalTip™ #1 - 00818365020096 Catalog Number :

Device Description : Universal diamond-coated apical surgery tip for the retro-preparation of canals

Device Class : 2

Duns Number: 078474365

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

EdgeSurgicalTip™ #2 - 00818365020102 Catalog Number :

Device Description : Universal diamond-coated apical surgery tip for the retro-preparation of canals

Device Class : 2

Duns Number: 078474365

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

EdgeSurgical Tip™ #3 - 00818365020119 Catalog Number :

Device Description : Diamond-coated left-angled retro tip for preparing pre-molar and molar canals

Device Class : 2

Duns Number: 078474365

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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