Device
VITAVM®LC PRIMER SET
Manufacturer
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Model: CVMLPSET
DI: J017CVMLPSET0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
VITAVM®LC PRIMER SET
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a6f1d313-6de7-44d6-ab4d-33972424c1ce
Distribution Status:
In Commercial Distribution
DUNS Number:
315165357
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
J017CVMLPSET0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 38781
Name: Dental prosthesis veneer resin
Definition:
A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.
FDA Product Codes
KLE
AGENT, TOOTH BONDING, RESIN
Premarket Submissions
Submission Number:
K251587
Supplement Number:
000