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Neodent 110.335

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

Neodent 110.335 is a Class II device made by JJGC Indústria e Comércio de Materiais Dentários S/A., cleared under FDA 510(k) K230804 on 7 Jul 2023 and listed in FDA GUDID since 18 Aug 2023 (UDI-DI 07899878061151), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K230804

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07899878061151 UDI-DI Date18 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230804 Date7 Jul 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230804 decided 7 Jul 2023 Active
  • FDA GUDID UDI-DI 07899878061151 listed 18 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230804
  2. Listed FDA GUDID 07899878061151

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neodent
Generic name
Instrument tray, reusable
Model / Ref / Catalog
110.335
Primary DI / UDI-DI
07899878061151
510(k) Number
FDA product code
KCT
GMDN term
Instrument tray, reusable
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Instrument tray, reusable.

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

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)