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Chaorum Implant System ATFW6014S

by Medimecca Co., Ltd.

Chaorum Implant System ATFW6014S is a Class II device made by Medimecca Co., Ltd., cleared under FDA 510(k) K160536 on 5 Jan 2017 and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 08806394608073), 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) K160536

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 Number08806394608073 UDI-DI Date31 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160536 Date5 Jan 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160536 decided 5 Jan 2017 Active
  • FDA GUDID UDI-DI 08806394608073 listed 31 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160536
  2. Listed FDA GUDID 08806394608073

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Chaorum Implant System
Generic name
Dental implant system
Model / reference
ATFW6014S
Primary DI / UDI-DI
08806394608073
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

Other devices from Medimecca Co., Ltd.

See all devices from Medimecca Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)