Preventech

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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

Varnish, Cavity (LBH) (10)

Premarket Exempt

Clear

VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 35 - D024772103 Catalog Number : 772103

Device Description : VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box of 35 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 35

VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35 - D024772105 Catalog Number : 772105

Device Description : VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35 ea. 0.5mL VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35 ea. 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 420

VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 100 - D024772113 Catalog Number : 772113

Device Description : VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box of 100 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 100

VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100 - D024772115 Catalog Number : 772115

Device Description : VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100 ea. 0.5m VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100 ea. 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 1200

VELLAmini 5% Sodium Fluoride Varnish Caramel Box 35 - D024772143 Catalog Number : 772143

Device Description : VELLAmini 5% Sodium Fluoride Varnish Caramel Box of 35 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 35

VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35 - D024772145 Catalog Number : 772145

Device Description : VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35 ea. 0.5mL un VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35 ea. 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 420

VELLAmini 5% Sodium Fluoride Varnish Caramel Box 100 - D024772153 Catalog Number : 772153

Device Description : VELLAmini 5% Sodium Fluoride Varnish Caramel Box of 100 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 100

VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100 - D024772155 Catalog Number : 772155

Device Description : VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100 0.5mL unit VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 1200

VELLAmini 5% Sodium Fluoride Varnish Spearmint Box 35 - D024772213 Catalog Number : 772213

Device Description : VELLAmini 5% Sodium Fluoride Varnish Spearmint Box of 35 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 35

VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35 - D024772215 Catalog Number : 772215

Device Description : VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35 ea. 0.5mL VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35 ea. 0.5mL unit dose packages

Device Class :

Duns Number: 090735093

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 420

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