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i-Clean Octa Abutment Healing Cap DIOWHCS

by Dentis Co., Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806169112071 UDI-DIDate22 May 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
i-Clean Octa Abutment Healing Cap
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Model / Reference
DIOWHCS
Primary DI / UDI-DI
08806169112071
510(k) Number
FDA Product Code
NHA
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class II
Regulation Number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Cleared under the same submission (K171027)

Show all (12)

Other devices from Dentis Co., Ltd

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No