Device
Universal Dentin Sealant Refill Universal
Manufacturer
ULTRADENT PRODUCTS, INC.
Model: 266 Catalog: 266 DI: 00883205045805 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Description
Universal Dentin Sealant Refill Universal
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 88c3bdc5-f6f5-4f8b-869a-4ae16e6426f7
Distribution Status: In Commercial Distribution
DUNS Number: 013369913
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: 00883205045805
Type: Primary
Issuing Agency: GS1
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: K963979
Supplement Number: 000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: 18
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: 29
Storage Handling - Storage Handling Type: Storage Environment Temperature