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Neodent Instruments Kits

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

510(k) K182865

Neodent Instruments Kits is a Class II device made by JJGC Indústria e Comércio de Materiais Dentários S/A., cleared under FDA 510(k) K182865 on 7 May 2019, active as of 22 Oct 2026.

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 NumberK182865 Date7 May 2019ClearedStatusActive

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  • Withdrawn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 Industria E Comercio DE Materiais Dentarios 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

Cited by

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

Devices cleared under K182865

7 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 K182865
UDI-DISize and differences
Neodent 110.287
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.287 / 110.28707899878027379
Width 163 mm; Height 54 mm; Length 264 mm
On the market
Neodent 110.294
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.294 / 110.29407899878029021
Width 90 mm; Height 54 mm; Length 195 mm
On the market
Neodent 110.295
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.295 / 110.29507899878029120
Width 90 mm; Length 195 mm; Height 44 mm
On the market
Neodent 110.296
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.296 / 110.29607899878029557
Height 58 mm; Width 163 mm; Length 264 mm
On the market
Neodent 110.304
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.304 / 110.30407899878033592
Length 195 mm
On the market
Neodent 110.305
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.305 / 110.30507899878033608
Length 195 mm
On the market
Neodent 110.336
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.336 / 110.33607899878062165
Width 90 mm; Height 44 mm; Length 195 mm
On the market

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