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Cagenix AccuFrame IC 1000-02

by Cagenix, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number90860002441910 UDI-DI Date16 Jul 2020ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Cagenix AccuFrame IC
Generic Name
Dental implant suprastructure, permanent, custom-made
Model / Reference
1000-02
Primary DI / UDI-DI
90860002441910
510(k) Number
FDA Product Code
NHA
GMDN Term
Dental implant suprastructure, permanent, custom-made
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, permanent, custom-made

Cleared under the same submission (K081157)

Other devices from Cagenix, Inc.

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number

Other properties (10)

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