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Magic Multiunit Abutment MACN45115

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

Magic Multiunit Abutment MACN45115 is a Class II device made by InnoBioSurg Co., Ltd(IBS implant Co., Ltd), cleared under FDA 510(k) K212517 on 15 Oct 2021 and listed in FDA GUDID since 6 May 2022 (UDI-DI 08800177374889), active as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800177374889 UDI-DI Date6 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK212517 Date15 Oct 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212517 decided 15 Oct 2021 Active
  • FDA GUDID UDI-DI 08800177374889 listed 6 May 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212517
  2. Listed FDA GUDID 08800177374889

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Magic Multiunit Abutment
Generic name
Dental implant system
Model / reference
MACN45115
Primary DI / UDI-DI
08800177374889
510(k) Number
FDA product code
NHA
GMDN term
Dental implant system
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Safe

Related devices

Category: Dental implant system

Cleared under the same submission (K212517)

and 8 more cleared under K212517

Similar devices in this category

Other devices filed under Dental implant system.

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

See all devices from InnoBioSurg Co., Ltd(IBS implant Co., Ltd) →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (8, all answered No)