Model: KRS010
DI: 18016200021546
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
KROMOPAN SIL putty soft (2x300ml) - NORMAL SET
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
16b81c44-4b9d-4d64-ad8e-2ddda7f0a0e0
Distribution Status:
In Commercial Distribution
DUNS Number:
436269609
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:
18016200021546
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35866
Name: Silicone dental impression material
Definition:
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
FDA Product Codes
ELW
Material, Impression
Premarket Submissions
Submission Number:
K201184
Supplement Number:
000