Model: UDA6547
DI: 08800076403895
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b6fa0b48-a978-41e6-954f-e82312b1e553
Distribution Status:
In Commercial Distribution
DUNS Number:
694514760
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:
08800076403895
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44879
Name: Dental implant suprastructure, permanent, preformed
Definition:
A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
FDA Product Codes
NHA
Abutment, Implant, Dental, Endosseous
Premarket Submissions
Submission Number:
K172100
Supplement Number:
000