EDGE ENDO LLC

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

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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 For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomiesin deciduous teeth.

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 EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic proceduresand may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).

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 For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for installation.Intended to restore carious lesions or structural defects in teeth temporarily. Intended for use in cavities Classes I, II, III, IV (inlaysand onlays) and as a restorative material for veneers, crowns and bridges.

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 EdgeEndo sodium hypochlorite is a sodium hypochlorite solution in water with wetting agents to lower surface tension.

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 EdgeEndo Chlohexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures.

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 EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures to remove the smear layer.

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 EdgeIce Refrigerant pulp vitality spray is used in dentistry for the purpose of thermo testing of tooth vitality. For professional dental use only.

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 Universal diamond-coated apical surgery tip for the retro-preparation of canals of anterior

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 Universal diamond-coated apical surgery tip for the retro-preparation of canals of anterior

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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