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DIRECTscan™ Adapter Kit - Complete DS-Kit

by Apollo Implant Components Sp Z O O GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05904890607019 UDI-DIDate4 Mar 2026ListedStatusListed 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  • Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name
DIRECTscan™ Adapter Kit - Complete
Generic Name
Dental implant abutment analog, intraoral-scanning, single-use
Model / Reference
DS-Kit
Primary DI / UDI-DI
05904890607019
FDA Product Code
NDP
GMDN Term
Dental implant abutment analog, intraoral-scanning, single-use
Device Class
Class I
Regulation Number
872.3980
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Apollo Implant Components Sp Z O O

See all devices from Apollo Implant Components Sp Z O O →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No