FDA.reportPublic FDA data

Universal

Primary DI
D003B10731000
Brand
Universal
Company
Dentsply International Inc.
Model
B1073100
Catalog number
B1073100
Device description
AIMRIGHT UNIVRSL AIMING RING
Published
2024-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
D003B10731000Direct MarkingHIBCC0
D003B10731001PrimaryHIBCC0

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
795572718
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0026243451Enhance® mini Finishing System6243456243452022-04-11
D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
D0026243851Enhance® mini Finishing System6243856243852022-04-11
D002624550001Polytrays62455000624550002022-07-07
D002624550011Polytrays62455001624550012022-07-07
D002624550021Polytrays62455002624550022022-07-07
D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
D0026076071Calibra® Bio Bioceramic Luting Cement6076076076072022-04-20
D0026590301Palodent® Sectional Matrix System6590306590302019-04-02
D0026590701Palodent® Sectional Matrix System6590706590702019-04-02
D0026631001AutoMate®6631006631002019-04-02
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21

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
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
D090086000370Bar, Alignment, UniversalDental Imaging Technologies CorporationEHA2022-12-06
D090100815220Bar, Alignment, BitewingDental Imaging Technologies CorporationEHA2022-12-06