FDA.reportPublic FDA data

Bar, Alignment, Universal

Primary DI
D090086000370
Brand
Bar, Alignment, Universal
Company
Dental Imaging Technologies Corporation
Model
0.860.0037
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHAAligner, Beam, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHAAligner, Beam, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D090086000370PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, reusableA device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800111106
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00693856000340DEXIS Imprevo SLIM TIPDEXIS Imprevo59456602026-08-07
D090101399140DEXIS IXS Size 2 Accessory Layer1.013.99142026-08-03
D090101399150DEXIS IXS Size 2 Accessory Layer1.013.99152026-08-03
D090101399160DEXIS IXS Size 2 Accessory Layer1.013.99162026-08-03
D090101399170DEXIS IXS Size 1 Accessory Layer1.013.99172026-08-03
D090101399180DEXIS IXS Size 1 Accessory Layer1.013.99182026-08-03
D090101399190DEXIS IXS Size 1 Accessory Layer1.013.99192026-08-03
D090101461070DEXIS IXS Size 1 Accessory Layer1.014.61072026-08-03
D090101461090DEXIS IXS Size 2 Accessory Layer1.013.29162026-08-03
D090101461480DEXIS Titanium Accessory Layer1.014.61482026-08-03
D090101461490DEXIS Titanium Accessory Layer1.014.61492026-08-03
D090101461500DEXIS Titanium Accessory Layer1.014.61502026-08-03
D090101461510DEXIS Titanium Accessory Layer1.014.61512026-08-03
D090101461520DEXIS Titanium Accessory Layer1.014.61522026-08-03
D090101397120IXS S2 Kit, CT, US, FR-CA1.013.97122026-05-12
00693856000203Assembly-IS 3700 SIDE TIPIS 3700TA08502025-12-04
00693856000227Assembly-IS 3700 POSTERIOR TIPIS 3700TA08602025-12-04
D090101329460DEXIS IXS Size 1 Sensor - R1.013.29461.013.29462026-04-01
D090101329470DEXIS IXS Size 2 Sensor - R1.013.29471.013.29472026-04-01
D090800045720DEXIS Ti2 Sensor - R - S8.000.45728.000.45722026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D090101399140DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399150DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399160DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399170DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399180DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399190DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461070DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461090DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461480DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461490DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461500DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461510DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461520DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D003B01200001SchickDentsply International Inc.EHA2024-11-06
D003B01210001SchickDentsply International Inc.EHA2024-11-06
D003B10731001UniversalDentsply International Inc.EHA2024-11-06
D003B01200000SchickDentsply International Inc.EHA2024-11-06
D003B01210000SchickDentsply International Inc.EHA2024-11-06
D003B01220001SchickDentsply International Inc.EHA2024-11-06
D003B10731000UniversalDentsply International Inc.EHA2024-11-06
D003B10731101AimRightDentsply International Inc.EHA2024-11-06
D003B24041001SchickDentsply International Inc.EHA2024-11-06
D003B24042001SchickDentsply International Inc.EHA2024-11-06
D7641000053341AimRightSIRONA DENTAL, INC.EHA2022-12-07
D764B02100001Intraoral Sensor Holders Arms and Rings SIRONA DENTAL, INC.EHA2022-12-07
D764B10731001Intraoral Sensor Holder Arms and RingsSIRONA DENTAL, INC.EHA2022-12-07
D764B10740501AimRight HolderSIRONA DENTAL, INC.EHA2022-12-07
D090082251290Endodontic Bar - Alignment BarDental Imaging Technologies CorporationEHA2022-12-06
D090086000360Bar, Alignment, Bitewing, DEXISDental Imaging Technologies CorporationEHA2022-12-06
D090100815220Bar, Alignment, BitewingDental Imaging Technologies CorporationEHA2022-12-06