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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  • Withdrawn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 453004
Gc America Inc.
453004 / 45300410386040012614
Single use: no
On the market
EQUIA 453005
Gc America Inc.
453005 / 45300510386040012621
Single use: no
On the market
EQUIA® 452000
Gc America Inc.
452000 / 45200010386040010474
Single use: yes
On the market
EQUIA® 452000
Gc America Inc.
452000 / 452000D6584520001
Single use: yes
On the market
EQUIA® 452002
Gc America Inc.
452002 / 45200210386040010498
Single use: yes
On the market
EQUIA® 452002
Gc America Inc.
452002 / 452002D6584520021
Single use: yes
On the market
EQUIA® 452003
Gc America Inc.
452003 / 45200310386040013871
Single use: yes
On the market
EQUIA® 452004
Gc America Inc.
452004 / 45200410386040010504
Single use: yes
On the market
EQUIA® 452004
Gc America Inc.
452004 / 452004D6584520041
Single use: yes
On the market
EQUIA® 452005
Gc America Inc.
452005 / 452005D6584520051
Single use: yes
On the market
EQUIA® 452005
Gc America Inc.
452005 / 45200510386040010511
Single use: yes
On the market
EQUIA® 452006
Gc America Inc.
452006 / 452006D6584520061
Single use: yes
On the market
EQUIA® 452006
Gc America Inc.
452006 / 45200610386040010528
Single use: yes
On the market
EQUIA® 452007
Gc America Inc.
452007 / 45200710386040010535
Single use: yes
On the market
EQUIA® 452007
Gc America Inc.
452007 / 452007D6584520071
Single use: yes
On the market
EQUIA® 452008
Gc America Inc.
452008 / 45200810386040010542
Single use: yes
On the market
EQUIA® 452008
Gc America Inc.
452008 / 452008D6584520081
Single use: yes
On the market
EQUIA® 452010
Gc America Inc.
452010 / 45201010386040010566
Single use: yes
On the market
EQUIA® 452010
Gc America Inc.
452010 / 452010D6584520101
Single use: yes
On the market
EQUIA® 452011
Gc America Inc.
452011 / 452011D6584520111
Single use: yes
On the market
EQUIA® 452012
Gc America Inc.
452012 / 45201210386040010580
Single use: yes
On the market
EQUIA® 452012
Gc America Inc.
452012 / 452012D6584520121
Single use: yes
On the market
EQUIA® 452013
Gc America Inc.
452013 / 452013D6584520131
Single use: yes
On the market
EQUIA® 452013
Gc America Inc.
452013 / 45201310386040010597
Single use: yes
On the market
EQUIA® 452014
Gc America Inc.
452014 / 45201410386040010603
Single use: yes
On the market
EQUIA® 452015
Gc America Inc.
452015 / 45201510386040010610
Single use: yes
On the market
EQUIA® 452016
Gc America Inc.
452016 / 452016D6584520161
Single use: yes
On the market
EQUIA® 453000
Gc America Inc.
453000 / 45300010386040010764
Single use: no
On the market
EQUIA® 453000
Gc America Inc.
453000 / 453000D6584530001
Single use: no
On the market
EQUIA® 453001
Gc America Inc.
453001 / 453001D6584530011
Single use: no
On the market
EQUIA® 453002
Gc America Inc.
453002 / 453002D6584530021
Single use: no
On the market
EQUIA® 453002
Gc America Inc.
453002 / 45300210386040012645
Single use: no
On the market
EQUIA® 453003
Gc America Inc.
453003 / 453003D6584530031
Single use: no
On the market
EQUIA® 453004
Gc America Inc.
453004 / 453004D6584530041
Single use: no
On the market
EQUIA® 453005
Gc America Inc.
453005 / 453005D6584530051
Single use: no
On the market
EQUIA® 453006
Gc America Inc.
453006 / 453006D6584530061
Single use: no
On the market
EQUIA® 453007
Gc America Inc.
453007 / 453007D6584530071
Single use: no
On the market
EQUIA® 453009
Gc America Inc.
453009 / 453009D6584530091
Single use: no
On the market
EQUIA® 453010
Gc America Inc.
453010 / 453010D6584530101
Single use: no
On the market
EQUIA® 453010
Gc America Inc.
453010 / 45301010386040010771
Single use: no
On the market
EQUIA® 453011
Gc America Inc.
453011 / 45301110386040010788
Single use: no
On the market
EQUIA® 453011
Gc America Inc.
453011 / 453011D6584530111
Single use: no
On the market
EQUIA® 453012
Gc America Inc.
453012 / 453012D6584530121
Single use: no
On the market
EQUIA® 453012
Gc America Inc.
453012 / 45301210386040010795
Single use: no
On the market
EQUIA® 453014
Gc America Inc.
453014 / 453014D6584530141
Single use: no
On the market
EQUIA® 453015
Gc America Inc.
453015 / 45301510386040010825
Single use: no
On the market
EQUIA® 453015
Gc America Inc.
453015 / 453015D6584530151
Single use: no
On the market
EQUIA® 453016
Gc America Inc.
453016 / 453016D6584530161
Single use: no
On the market
EQUIA® 453016
Gc America Inc.
453016 / 45301610386040010832
Single use: no
On the market
EQUIA® 453017
Gc America Inc.
453017 / 45301710386040010849
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. →