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Neodent 109.1055

by JJGC Indústria e Comércio de Materiais Dentários S/A.

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 Number07899878032021 UDI-DI Date10 Aug 2023ListedStatusListed 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  • Withdrawn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
Neodent
Generic Name
Screw endosteal dental implant, one-piece
Model / Ref / Catalog
109.1055
Primary DI / UDI-DI
07899878032021
FDA Product Code
DZE
GMDN Term
Screw endosteal dental implant, one-piece
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 47.5 Millimeter
Outer Diameter — 4.0 Millimeter

Related devices

Category: Screw endosteal dental implant, one-piece

Cleared under the same submission (K190718)

Other devices from JJGC Indústria e Comércio de Materiais Dentários S/A.

See all devices from JJGC Indústria e Comércio de Materiais Dentários S/A. →

Properties

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

Other properties (6)

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