Device
Self-curing acrylic resin for the fabrication of temporary crowns and bridges in dentistry.
Manufacturer
MAJOR PRODOTTI DENTARI SPA
MAJOR PRODOTTI DENTARI SPA
Model: STANDARD SET
Catalog: B4100
DI: 08056640076792
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 the fabrication of temporary crowns and bridges in dentistry.
Poly-methylmethacrylate (PMMA) based powder and liquid system, supplied in Standard-Set configuration (6 powder jars of 100 g each and 2 liquid bottles of 100 mL each). Classified as ISO 10477:2020 Type 1. Single-use, non-sterile device intended for professional use by dental practitioners.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8ef5c3f1-d8d6-4d55-bcd6-d8963a7ce319
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:
08056640076792
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 31783
Name: Temporary dental crown/bridge
Definition:
A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].
FDA Product Codes
EBG
Crown And Bridge, Temporary, Resin
Premarket Submissions
Submission Number:
K082700
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