Model: S4551
Catalog: S4551
DI: 00883205045928
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
Peak Universal Bond Sample
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cea43c39-60a1-4a7d-95e8-035f61333c7d
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:
00883205045928
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34782
Name: Dentine bonding agent/set
Definition:
A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.
FDA Product Codes
KLE
AGENT, TOOTH BONDING, RESIN
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:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature