Device
Fluoride-containing dental desensitising varnish (5% NaF) + BioMin
Manufacturer
VOCO GmbH
Model: 2268 Catalog: 2268 DI: E22122681 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-06 Current Version: 2026-05-14
Description
Fluoride-containing dental desensitising varnish (5% NaF) + BioMin
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: dce7ee51-324e-4269-81ca-dde19f47028a
Distribution Status: In Commercial Distribution
DUNS Number: 316699578
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: E22122681
Type: Primary
Issuing Agency: HIBCC
GMDN
Code: 64794
Name: Dental coating, tooth-desensitizing, professional
Definition:
A substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.
FDA Product Codes
LBH
Varnish, Cavity
Premarket Submissions
Submission Number: K252073
Supplement Number: 000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: 4
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: 23
Storage Handling - Storage Handling Type: Storage Environment Temperature