Model: S3529
Catalog: S3529
DI: 00883205045904
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
Sample U-Seal XT Hydro
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0ba423ff-8d7f-4526-a86a-e6fc9f506263
Distribution Status:
In Commercial Distribution
DUNS Number:
013369913
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
00883205045904
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34771
Name: Dental unfilled resin sealant/coating
Definition:
A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.
FDA Product Codes
EBC
SEALANT, PIT AND FISSURE, AND CONDITIONER
Premarket Submissions
Submission Number:
K112517
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
27
Storage Handling - Storage Handling Type:
Storage Environment Temperature