Device
Solventum™ Paradigm™ Penta™ Fast Set VPS Impression MaterialHydrophilic, 36717, 600 mL base, 120 mL catalyst, 2/PAC
Manufacturer
Solventum Germany GmbH
Solventum Germany GmbH
Model: 36717
Catalog: 36717
DI: 00197998018947
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
Solventum™ Paradigm™ Penta™ Fast Set VPS Impression MaterialHydrophilic, 36717, 600 mL base, 120 mL catalyst, 2/PAC
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
563a4718-caf2-4fd5-912a-e270a049a579
Distribution Status:
In Commercial Distribution
DUNS Number:
315518329
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00197998018947
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