Model: 54003406
DI: EBRE540034060
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
breCAM.HIPC Ø 98,4 x 20mm C2 1 Piece
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8edd2cfe-9c6a-499b-8860-60e8376e08c3
Distribution Status:
In Commercial Distribution
DUNS Number:
341086190
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:
EBRE540034060
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 62817
Name: Dental appliance fabrication material, combination-material
Definition:
A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
FDA Product Codes
ELM
Denture, Plastic, Teeth
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
20
Item #1 - Size Type:
Height
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
98.4
Item #2 - Size Type:
Outer Diameter
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:
keep out of sunlight