Model: 4.20mm diameter x 16mm length
Catalog: BIO-F4216
DI: 07290119312801
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f5c0bd23-a279-481d-935a-1cf3386c7669
Distribution Status:
In Commercial Distribution
DUNS Number:
532209134
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:
07290119312801
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55847
Name: Dental implant system
Definition:
A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.
FDA Product Codes
DZE
Implant, Endosseous, Root-Form
Premarket Submissions
Submission Number:
K250872
Supplement Number:
000