Device
Light-curing, 1-component self-etching adhesive to create a permanent marginal-gap-free adhesion between the tooth structure (dentine, enamel) and the light-curing filling/ fixing...
Manufacturer
Saremco Dental AG
Saremco Dental AG
Model: /
Catalog: 8013
DI: D93180131
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
Light-curing, 1-component self-etching adhesive to create a permanent marginal-gap-free adhesion between the tooth structure (dentine, enamel) and the light-curing filling/ fixing material.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4f5aadea-12ec-4600-b641-d40a7a37f98b
Distribution Status:
In Commercial Distribution
DUNS Number:
480619001
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:
D93180131
Type:
Primary
Issuing Agency:
HIBCC
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
Premarket Submissions
Submission Number:
K252151
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:
28
Storage Handling - Storage Handling Type:
Storage Environment Temperature