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Magicore R 554M5009

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 1 Jun 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 1 Jun 2026. What this means

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800039300438 UDI-DI Date8 Oct 2018ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 1 Jun 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Dental implant system
Model / Reference
Magicore R
Primary DI / UDI-DI
08800039300438
510(k) Number
FDA Product Code
NHA, DZE
GMDN Term
Dental implant system
Device Class
Class II
Regulation Number
872.3630, 872.3640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental implant system

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

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Properties

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

Other properties (7)

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