RIBBOND, INC

Address:1904 3rd AVE STE 330,SEATTLE,WA,98101,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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (6) Agent, Tooth Bonding, Resin (KLE) (1) Material, Tooth Shade, Resin (EBF) (1) Plugger, Root Canal, Endodontic (EKR) (1) Scissors, Collar And Crown (EIR) (1)

Premarket Exempt

No Yes

Clear

Ribbond Securing Composite - D046CC0 Catalog Number : TIPS

Device Description : High viscosity flowable composite. Light cured micro hybrid.

Device Class : 2

Duns Number: 796596989

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Ribbond Bondable Reinfocement Ribbon - D758O0 Catalog Number :

Device Description : Dental fiber reinforcement.

Device Class : 2

Duns Number: 796596989

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Ribbond Bondable Reinfocement Ribbon Kit - D758OK0 Catalog Number :

Device Description : Dental fiber reinforcement Kit

Device Class : 2

Duns Number: 796596989

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Ribbond Wetting Resin - D758RR0 Catalog Number : RESIN

Device Description : light curing, unfilled dental adhesive used as an interface between Ribbond fib light curing, unfilled dental adhesive used as an interface between Ribbond fibers and composite.

Device Class : 2

Duns Number: 796596989

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

Ribbond Scissors - D758SCISSORS1 Catalog Number : SCISSORS

Device Description : Scissors to cut tough Ribbond reinforcement fibers. Used extra-orally.

Device Class : 1

Duns Number: 796596989

Premarket Exempt : Yes

Product Code : EIR

Prescription Use : No

Device Count : 1

Ribbond Bondable Reinfocement Ribbon - D758T0 Catalog Number :

Device Description : Dental fiber reinforcement THM (Thinner Higher Modulus)

Device Class : 2

Duns Number: 796596989

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Ribbond Bondable Reinfocement Ribbon Kit - D758TK0 Catalog Number :

Device Description : Dental fiber reinforcement THM (Thinner Higher Modulus) Kit

Device Class : 2

Duns Number: 796596989

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Ribbond Placement Instrument - D758TX5070 Catalog Number : ENIN

Device Description : Ribbond Placement Instrument

Device Class : 1

Duns Number: 796596989

Premarket Exempt : Yes

Product Code : EKR

Prescription Use : Yes

Device Count : 1

Ribbond Bondable Reinfocement Ribbon - D758U0 Catalog Number :

Device Description : Dental fiber reinforcement Ultra thin

Device Class : 2

Duns Number: 796596989

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Ribbond Bondable Reinfocement Ribbon Kit - D758UK0 Catalog Number :

Device Description : Dental fiber reinforcement Ultra thin Kit

Device Class : 2

Duns Number: 796596989

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

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