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Dexis Sensor

by Dexis LLC

510(k) K090458

Dexis Sensor is a Class II device made by Dexis LLC, cleared under FDA 510(k) K090458 on 28 May 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 NumberK090458 Date28 May 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  • Withdrawn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
MUH
FDA applicant
Dexis, LLC
Device class
Class II
Regulation
21 CFR Part 872.1800
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 K090458

40 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 K090458
UDI-DISize and differences
DEXIS Platinum™ intraoral sensor 0.822.5071
DEXIS LLC
PLU5101S / 0.822.5071EKAV082250710
Prescription: yes
On the market
DEXIS Platinum™ intraoral sensor 0.822.5073
DEXIS LLC
PLU5102C / 0.822.5073EKAV082250730
Prescription: yes
On the market
DEXIS Platinum™ intraoral sensor 0.822.5074
DEXIS LLC
PLU5102S / 0.822.5074EKAV082250740
Prescription: yes
On the market
DEXIS Platinum™ intraoral sensor 0.822.5194
DEXIS LLC
PLU690 / 0.822.5194EKAV082251940
Prescription: yes
On the market
DEXIS Platinum™ intraoral sensor 1.007.3042
DEXIS LLC
PLU5101I / 1.007.3042EKAV100730420
Prescription: yes
On the market
DEXIS Platinum™ intraoral sensor 1.008.9874
DEXIS LLC
PLU690K / 1.008.9874EKAV100898740
Prescription: yes
On the market
DEXIS Platinum™ intraoral sensor 1.008.9877
DEXIS LLC
PLU690R / 1.008.9877EKAV100898770
Prescription: yes
On the market
DEXIS Platinum™ intraoral sensor 1.011.8417
DEXIS LLC
PLU5109S / 1.011.8417EKAV101184170
Prescription: yes
On the market
DEXIS Platinum™ intraoral sensor 1.011.8419
DEXIS LLC
PLU5109I / 1.011.8419EKAV101184190
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 0.822.4598
GENDEX CORP.
120 0211G1 / 0.822.4598EKAV082245980
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 0.822.4599
GENDEX CORP.
120 0212G1 / 0.822.4599EKAV082245990
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 0.822.5011
GENDEX CORP.
GXS70001 / 0.822.5011EKAV082250110
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 0.822.5012
GENDEX CORP.
GXS70002 / 0.822.5012EKAV082250120
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 0.822.5013
GENDEX CORP.
GXS70012 / 0.822.5013EKAV082250130
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.007.6200
GENDEX CORP.
GXS70001S / 1.007.6200EKAV100762000
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.007.6201
GENDEX CORP.
GXS70002S / 1.007.6201EKAV100762010
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.007.6202
GENDEX CORP.
GXS70012S / 1.007.6202EKAV100762020
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.008.5052
GENDEX CORP.
GXS70012S / 1.008.5052EKAV100850520
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.008.5053
GENDEX CORP.
10085053 / 1.008.5053EKAV100850530
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.008.5054
GENDEX CORP.
10085054 / 1.008.5054EKAV100850540
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.008.5055
GENDEX CORP.
10085055 / 1.008.5055EKAV100850550
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.010.7654
GENDEX CORP.
10107654 / 1.010.7654EKAV101076540
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.010.7655
GENDEX CORP.
10107655 / 1.010.7655EKAV101076550
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.010.7656
GENDEX CORP.
10107656 / 1.010.7656EKAV101076560
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.010.7863
GENDEX CORP.
10107863 / 1.010.7863EKAV101078630
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.010.7864
GENDEX CORP.
10107864 / 1.010.7864EKAV101078640
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.010.8118
GENDEX CORP.
10108118 / 1.010.8118EKAV101081180
Prescription: yes
On the market
Gendex GXS-700™ intraoral sensor 1.010.8119
GENDEX CORP.
10108119 / 1.010.8119EKAV101081190
Prescription: yes
On the market
KaVo GXS-700 Sensor Size 1 1.012.8977
GENDEX CORP.
1.012.8977 / 1.012.8977EKAV101289770
Prescription: yes
On the market
KaVo GXS-700 Sensor Size 2 1.012.8978
GENDEX CORP.
1.012.8978 / 1.012.8978EKAV101289780
Prescription: yes
On the market
KaVo GXS-700™ intraoral sensor 1.012.9156
GENDEX CORP.
1.012.9156EKAV101291560
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.012.9157
GENDEX CORP.
1.012.9157EKAV101291570
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.012.9158
GENDEX CORP.
1.012.9158EKAV101291580
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.012.9159
GENDEX CORP.
1.012.9159EKAV101291590
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.012.9160
GENDEX CORP.
1.012.9160EKAV101291600
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.012.9161
GENDEX CORP.
1.012.9161EKAV101291610
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.013.0511
GENDEX CORP.
1.013.0511EKAV101305110
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.013.0512
GENDEX CORP.
1.013.0512EKAV101305120
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.013.0513
GENDEX CORP.
1.013.0513EKAV101305130
Prescription: no
On the market
KaVo GXS-700™ intraoral sensor 1.013.0514
GENDEX CORP.
1.013.0514EKAV101305140
Prescription: no
On the market

Similar devices

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