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Healing Cap MP CAP 5.5

by InnoBioSurg Co., Ltd(IBS implant Co., Ltd) 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 1 Jun 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 1 Jun 2026. What this means

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800039301060 UDI-DI Date5 Oct 2018ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 1 Jun 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Screw endosteal dental implant, one-piece
Model / Reference
Healing Cap
Primary DI / UDI-DI
08800039301060
510(k) Number
FDA Product Code
NHA, DZE
GMDN Term
Screw endosteal dental implant, one-piece
Device Class
Class II
Regulation Number
872.3630, 872.3640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Screw endosteal dental implant, one-piece

Cleared under the same submission (K152520)

Show all (12)

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

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No