Device
Self-curing acrylic resin for denture relining, repairing and rebasing in dental prosthesis.
Manufacturer
MAJOR PRODOTTI DENTARI SPA
MAJOR PRODOTTI DENTARI SPA
Model: STANDARD-SET MV
Catalog: C3121-MV
DI: 08056640078857
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Self-curing acrylic resin for denture relining, repairing and rebasing in dental prosthesis.
Poly-methylmethacrylate (PMMA) based powder and liquid system, supplied in Standard-Set configuration. Shade MV.
Classified as ISO 20795-1:2013 Type 2 Class 1.
Single-use, non-sterile device intended for professional use by dental laboratory technicians and dental practitioners.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9f474214-d72d-46f9-8784-9731edf3cfb2
Distribution Status:
In Commercial Distribution
DUNS Number:
459034567
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:
08056640078857
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16730
Name: Dental appliance fabrication material, resin
Definition:
A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
FDA Product Codes
EBI
Resin, Denture, Relining, Repairing, Rebasing
Premarket Submissions
Submission Number:
K082153
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Keep dry
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Protect from sunlight