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Magicore S 451M5012S

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

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K192197

FDA submission, from GUDID

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 Number08800177311105 UDI-DI Date25 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192197 Date28 Apr 2020DecidedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
Magicore S
Generic name
Dental implant system
Model / reference
451M5012S
Primary DI / UDI-DI
08800177311105
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

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (7)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No