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Dual Top Screw System / Dual Top Anchor System S13-JK-007

by Jeil Medical Corporation

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 Number08800089426867 UDI-DI Date11 Jan 2022ListedStatusListed 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  • Withdrawn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
Dual Top Screw System / Dual Top Anchor System
Generic Name
Orthodontic anchoring screw
Model / Reference
S13-JK-007
Primary DI / UDI-DI
08800089426867
510(k) Number
FDA Product Code
OAT
GMDN Term
Orthodontic anchoring screw
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic anchoring screw

Cleared under the same submission (K161335)

Show all (12)

Other devices from Jeil Medical Corporation

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Properties

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

Other properties (7)

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