Model: 121.0005
Catalog: 121.0005
DI: 07640462720691
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
NV.C, NP, Cover Screw
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
44dd0bf9-f323-4fc2-b555-8f02e4c2f52c
Distribution Status:
In Commercial Distribution
DUNS Number:
487322770
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:
07640462720691
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44880
Name: Dental implant suprastructure, temporary, preformed, single-use
Definition:
A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.
FDA Product Codes
NHA
Abutment, Implant, Dental, Endosseous
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Keep away from sunlight