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Estelite Universal Flow

by Tokuyama Dental Corporation

510(k) K180613

Estelite Universal Flow is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K180613 on 12 Jul 2018, 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 NumberK180613 Date12 Jul 2018ClearedStatusActive

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  • Withdrawn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
EBF
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
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

Devices cleared under K180613

52 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 K180613
UDI-DISize and differences
ESTELITE UNIVERSAL FLOW 13875
TOKUYAMA DENTAL CORPORATION
1387504548190138753
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13876
TOKUYAMA DENTAL CORPORATION
1387604548190138760
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13877
TOKUYAMA DENTAL CORPORATION
1387704548190138777
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13878
TOKUYAMA DENTAL CORPORATION
1387804548190138784
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13879
TOKUYAMA DENTAL CORPORATION
1387904548190138791
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13880
TOKUYAMA DENTAL CORPORATION
1388004548190138807
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13881
TOKUYAMA DENTAL CORPORATION
1388104548190138814
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13882
TOKUYAMA DENTAL CORPORATION
1388204548190138821
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13884
TOKUYAMA DENTAL CORPORATION
1388404548190138845
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13885
TOKUYAMA DENTAL CORPORATION
1388504548190138852
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13886
TOKUYAMA DENTAL CORPORATION
1388604548190138869
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13887
TOKUYAMA DENTAL CORPORATION
1388704548190138876
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13888
TOKUYAMA DENTAL CORPORATION
1388804548190138883
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13889
TOKUYAMA DENTAL CORPORATION
1388904548190138890
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13890
TOKUYAMA DENTAL CORPORATION
1389004548190138906
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13891
TOKUYAMA DENTAL CORPORATION
1389104548190138913
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13892
TOKUYAMA DENTAL CORPORATION
1389204548190138920
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13893
TOKUYAMA DENTAL CORPORATION
1389304548190138937
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13894
TOKUYAMA DENTAL CORPORATION
1389404548190138944
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13895
TOKUYAMA DENTAL CORPORATION
1389504548190138951
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13896
TOKUYAMA DENTAL CORPORATION
1389604548190138968
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13897
TOKUYAMA DENTAL CORPORATION
1389704548190138975
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13898
TOKUYAMA DENTAL CORPORATION
1389804548190138982
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13899
TOKUYAMA DENTAL CORPORATION
1389904548190138999
Single use: no
On the market
ESTELITE UNIVERSAL FLOW 13975
TOKUYAMA DENTAL CORPORATION
1397504548190139750
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13976
TOKUYAMA DENTAL CORPORATION
1397604548190139767
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13977
TOKUYAMA DENTAL CORPORATION
1397704548190139774
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13978
TOKUYAMA DENTAL CORPORATION
1397804548190139781
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13979
TOKUYAMA DENTAL CORPORATION
1397904548190139798
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13980
TOKUYAMA DENTAL CORPORATION
1398004548190139804
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13981
TOKUYAMA DENTAL CORPORATION
1398104548190139811
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13982
TOKUYAMA DENTAL CORPORATION
1398204548190139828
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13983
TOKUYAMA DENTAL CORPORATION
1398304548190139835
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13984
TOKUYAMA DENTAL CORPORATION
1398404548190139842
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13985
TOKUYAMA DENTAL CORPORATION
1398504548190139859
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13986
TOKUYAMA DENTAL CORPORATION
1398604548190139866
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13987
TOKUYAMA DENTAL CORPORATION
1398704548190139873
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13988
TOKUYAMA DENTAL CORPORATION
1398804548190139880
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13989
TOKUYAMA DENTAL CORPORATION
1398904548190139897
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13990
TOKUYAMA DENTAL CORPORATION
1399004548190139903
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13991
TOKUYAMA DENTAL CORPORATION
1399104548190139910
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13992
TOKUYAMA DENTAL CORPORATION
1399204548190139927
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13994
TOKUYAMA DENTAL CORPORATION
1399404548190139941
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13995
TOKUYAMA DENTAL CORPORATION
1399504548190139958
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13996
TOKUYAMA DENTAL CORPORATION
1399604548190139965
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13997
TOKUYAMA DENTAL CORPORATION
1399704548190139972
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13998
TOKUYAMA DENTAL CORPORATION
1399804548190139989
Single use: yes
On the market
ESTELITE UNIVERSAL FLOW 13999
TOKUYAMA DENTAL CORPORATION
1399904548190139996
Single use: yes
On the market
OMNICHROMA BLOCKER FLOW 10222
TOKUYAMA DENTAL CORPORATION
1022204548190102228
Single use: no
On the market
OMNICHROMA FLOW 10224
TOKUYAMA DENTAL CORPORATION
1022404548190102242
Single use: no
On the market

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