Skip to content

E-1 Esthetic Composite System

by Tokuyama Dental Corporation

510(k) K072746

E-1 Esthetic Composite System is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K072746 on 4 Dec 2007, 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 NumberK072746 Date4 Dec 2007ClearedStatusActive

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  • Withdrawn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

Devices cleared under K072746

26 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 K072746
UDI-DISize and differences
Estelite Omega 10701
TOKUYAMA DENTAL CORPORATION
1070104548190107018
Single use: no
On the market
Estelite Omega 10702
TOKUYAMA DENTAL CORPORATION
1070204548190107025
Single use: no
On the market
Estelite Omega 10711
TOKUYAMA DENTAL CORPORATION
1071104548190107117
Single use: yes
On the market
Estelite Omega 10712
TOKUYAMA DENTAL CORPORATION
1071204548190107124
Single use: yes
On the market
Estelite Omega 10721
TOKUYAMA DENTAL CORPORATION
1072104548190107216
Single use: no
On the market
Estelite Omega 10722
TOKUYAMA DENTAL CORPORATION
1072204548190107223
Single use: no
On the market
Estelite Omega 10723
TOKUYAMA DENTAL CORPORATION
1072304548190107230
Single use: no
On the market
Estelite Omega 10724
TOKUYAMA DENTAL CORPORATION
1072404548190107247
Single use: no
On the market
Estelite Omega 10725
TOKUYAMA DENTAL CORPORATION
1072504548190107254
Single use: no
On the market
Estelite Omega 10726
TOKUYAMA DENTAL CORPORATION
1072604548190107261
Single use: no
On the market
Estelite Omega 10727
TOKUYAMA DENTAL CORPORATION
1072704548190107278
Single use: no
On the market
Estelite Omega 10728
TOKUYAMA DENTAL CORPORATION
1072804548190107285
Single use: no
On the market
Estelite Omega 10729
TOKUYAMA DENTAL CORPORATION
1072904548190107292
Single use: no
On the market
Estelite Omega 10730
TOKUYAMA DENTAL CORPORATION
1073004548190107308
Single use: no
On the market
Estelite Omega 10731
TOKUYAMA DENTAL CORPORATION
1073104548190107315
Single use: no
On the market
Estelite Omega 10741
TOKUYAMA DENTAL CORPORATION
1074104548190107414
Single use: yes
On the market
Estelite Omega 10742
TOKUYAMA DENTAL CORPORATION
1074204548190107421
Single use: yes
On the market
Estelite Omega 10743
TOKUYAMA DENTAL CORPORATION
1074304548190107438
Single use: yes
On the market
Estelite Omega 10744
TOKUYAMA DENTAL CORPORATION
1074404548190107445
Single use: yes
On the market
Estelite Omega 10745
TOKUYAMA DENTAL CORPORATION
1074504548190107452
Single use: yes
On the market
Estelite Omega 10746
TOKUYAMA DENTAL CORPORATION
1074604548190107469
Single use: yes
On the market
Estelite Omega 10747
TOKUYAMA DENTAL CORPORATION
1074704548190107476
Single use: yes
On the market
Estelite Omega 10748
TOKUYAMA DENTAL CORPORATION
1074804548190107483
Single use: yes
On the market
Estelite Omega 10749
TOKUYAMA DENTAL CORPORATION
1074904548190107490
Single use: yes
On the market
Estelite Omega 10750
TOKUYAMA DENTAL CORPORATION
1075004548190107506
Single use: yes
On the market
Estelite Omega 10751
TOKUYAMA DENTAL CORPORATION
1075104548190107513
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code EBF (Material, Tooth Shade, Resin).

Other devices from Tokuyama Dental Corporation

See all devices from Tokuyama Dental Corporation →