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Magicore 501MC6510

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) K212517

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 Number08800177357356 UDI-DI Date20 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK212517 Date15 Oct 2021DecidedStatusActive

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  • Withdrawn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
Generic name
Dental implant system
Model / reference
501MC6510
Primary DI / UDI-DI
08800177357356
510(k) Number
FDA product code
DZE, NHA
GMDN term
Dental implant system
Device class
Class II
Regulation number
872.3640, 872.3630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental implant system

Cleared under the same submission (K212517)

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