Skip to content

Complement Kit Cases

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

510(k) K230804

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230804 Date7 Jul 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KCT
FDA applicant
JJGC Indústria e Comércio de Materiais Dentários S.A.
Device class
Class II
Regulation
21 CFR Part 880.6850
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Complement Kit Cases are sterilization wrap containers designed to protect and organize dental instruments and accessories during sterilization processes. These cases provide a structured solution for maintaining the integrity and sterility of items within a dental setting, ensuring compliance with infection control protocols.

Supplied as reusable containers, these cases are intended for use in general hospital and dental office environments. They are classified under 21 CFR 880.6850 as sterilization wrap accessories and have received FDA 510(k) clearance (K230804) under the Traditional pathway. No specific sterility or MRI safety information is provided, and sizes or additional technical specifications are not detailed in the regulatory submission.

Devices cleared under K230804

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K230804
UDI-DISize and differences
Neodent 110.335
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.335 / 110.33507899878061151 —On the market
Nuvo CD1099002
JJGC Indústria e Comércio de Materiais Dentários S/A.
CD1099002 / CD109900207899878061144 —On the market

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. →