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ESTELITE BULK FILL Flow

by Tokuyama Dental Corporation

510(k) K161353

ESTELITE BULK FILL Flow is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K161353 on 3 Apr 2017, 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 NumberK161353 Date3 Apr 2017ClearedStatusActive

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  • Withdrawn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

Cited by

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

Devices cleared under K161353

11 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 K161353
UDI-DISize and differences
Estelite Bulk Fill Flow 12715
TOKUYAMA DENTAL CORPORATION
1271504548190127153
Single use: no
On the market
Estelite Bulk Fill Flow 12716
TOKUYAMA DENTAL CORPORATION
1271604548190127160
Single use: no
On the market
Estelite Bulk Fill Flow 12717
TOKUYAMA DENTAL CORPORATION
1271704548190127177
Single use: no
On the market
Estelite Bulk Fill Flow 12718
TOKUYAMA DENTAL CORPORATION
1271804548190127184
Single use: no
On the market
Estelite Bulk Fill Flow 12719
TOKUYAMA DENTAL CORPORATION
1271904548190127191
Single use: no
On the market
Estelite Bulk Fill Flow 12735
TOKUYAMA DENTAL CORPORATION
1273504548190127351
Single use: yes
On the market
Estelite Bulk Fill Flow 12736
TOKUYAMA DENTAL CORPORATION
1273604548190127368
Single use: yes
On the market
Estelite Bulk Fill Flow 12737
TOKUYAMA DENTAL CORPORATION
1273704548190127375
Single use: yes
On the market
Estelite Bulk Fill Flow 12738
TOKUYAMA DENTAL CORPORATION
1273804548190127382
Single use: yes
On the market
Estelite Bulk Fill Flow 12739
TOKUYAMA DENTAL CORPORATION
1273904548190127399
Single use: yes
On the market
Estelite Bulk Fill Flow 12744
TOKUYAMA DENTAL CORPORATION
1274404548190127443
Single use: yes
On the market

Similar devices

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

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