AXA Abutment AXBDRS58630

by Megagen Implant Co. Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08809985661815 UDI-DI	Date10 Jul 2024Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: AXA Abutment
Generic Name: Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog: AXBDRS58630, AXBDRS58630TC

Primary DI / UDI-DI: 08809985661815
510(k) Number: K233450
FDA Product Code: NHA
GMDN Term: Dental implant suprastructure, permanent, preformed

Device Class: Class II
Regulation Number: 872.3630
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization
MRI Safety: MR Conditional

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number
Serial Number
Manufacturing Date

Other properties (8)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Expiration Date: No