Model: A-PADE-AA380-453
Catalog: A-PADE-AA380-453
DI: D7702680253
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
P.A.D. ABUTMENT 45GR ANG. EST. H3 MM, D.3.80 MM
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:
f136c5c4-bae3-4764-be6a-694ba1c4f218
Distribution Status:
In Commercial Distribution
DUNS Number:
433815198
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D7702680253
Type:
Primary
Issuing Agency:
HIBCC
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:
K142242
Supplement Number:
000