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Magicore S 552MC6011S

by InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800177340266 UDI-DI Date19 Dec 2024ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Magicore S
Generic Name
Dental implant system
Model / Reference
552MC6011S
Primary DI / UDI-DI
08800177340266
510(k) Number
FDA Product Code
DZE
GMDN Term
Dental implant system
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Dental implant system

Cleared under the same submission (K192197)

Show all (12)

Other devices from InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

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Properties

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

Other properties (6)

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