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Equia

by Gc America Inc.

510(k) K091106

Equia is a Class II device made by Gc America Inc., cleared under FDA 510(k) K091106 on 17 Jun 2009, 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 NumberK091106 Date17 Jun 2009ClearedStatusActive

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  • Withdrawn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
EMA
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3275
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

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

Cited by

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

Devices cleared under K091106

69 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 K091106
UDI-DISize and differences
EQUIA 453001
Gc America Inc.
453001 / 45300110386040012591
Single use: no
On the market
EQUIA 453003
Gc America Inc.
453003 / 45300310386040012607
Single use: no
On the market
EQUIA® 452001
Gc America Inc.
452001 / 452001D6584520011
Single use: yes
On the market
EQUIA® 452001
Gc America Inc.
452001 / 45200110386040010481
Single use: yes
On the market
EQUIA® 452003
Gc America Inc.
452003 / 452003D6584520031
Single use: yes
On the market
EQUIA® 452009
Gc America Inc.
452009 / 45200910386040010559
Single use: yes
On the market
EQUIA® 452009
Gc America Inc.
452009 / 452009D6584520091
Single use: yes
On the market
EQUIA® 452011
Gc America Inc.
452011 / 45201110386040010573
Single use: yes
On the market
EQUIA® 452014
Gc America Inc.
452014 / 452014D6584520141
Single use: yes
On the market
EQUIA® 452015
Gc America Inc.
452015 / 452015D6584520151
Single use: yes
On the market
EQUIA® 452016
Gc America Inc.
452016 / 45201610386040010627
Single use: yes
On the market
EQUIA® 452017
Gc America Inc.
452017 / 452017D6584520171
Single use: yes
On the market
EQUIA® 452017
Gc America Inc.
452017 / 45201710386040010634
Single use: yes
On the market
EQUIA® 453008
Gc America Inc.
453008 / 453008D6584530081
Single use: no
On the market
EQUIA® 453009
Gc America Inc.
453009 / 45300910386040012638
Single use: no
On the market
EQUIA® 453013
Gc America Inc.
453013 / 45301310386040010801
Single use: no
On the market
EQUIA® 453013
Gc America Inc.
453013 / 453013D6584530131
Single use: no
On the market
EQUIA® 453014
Gc America Inc.
453014 / 45301410386040010818
Single use: no
On the market
EQUIA® 453017
Gc America Inc.
453017 / 453017D6584530171
Single use: no
On the market

Similar devices

Other devices filed under FDA product code EMA (Cement, Dental).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →