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N/A Msc-IBS7

by Southern Implants (Pty) Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06009544028581 UDI-DI Date20 Sep 2022ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1386-2018 FDA Class II initiated 8 Mar 2018 on shared 510(k) K163634

    The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Screw endosteal dental implant, two-piece
Model / Reference
MSC-IBS7
Primary DI / UDI-DI
06009544028581
510(k) Number
FDA Product Code
DZE
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Screw endosteal dental implant, two-piece

Cleared under the same submission (K163634)

Show all (12)

Other devices from Southern Implants (Pty) Ltd

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