N/A Eq-Ib-4

by Southern Implants (Pty) Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06009544027102 UDI-DI	Date9 Nov 2022Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-1386-2018 FDA Class II initiated 8 Mar 2018
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Dental implant suprastructure, permanent, preformed
Model / Reference: EQ-IB-4

Primary DI / UDI-DI: 06009544027102
510(k) Number: K163634
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

MRI Safety: MR Conditional

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Class II
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Class II
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Class II
N/A Bl-DC3-11

Class II
N/A Bl-DC5-11

Class II

See all devices from Southern Implants (Pty) Ltd →

Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (7)

Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No