FDA.reportPublic FDA data

RINN®

Primary DI
D0035500711
Brand
RINN®
Company
Dentsply International Inc.
Model
550071
Catalog number
550071
Device description
RINN® XCP-ORA® Single In Bag
Published
2022-11-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
D0035500711PrimaryHIBCC0
D0035500710Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
795572718
Device count
2
Premarket exempt
true
Lot or batch
true

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
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
D090086000370Bar, Alignment, UniversalDental Imaging Technologies CorporationEHA2022-12-06
D090100815220Bar, Alignment, BitewingDental Imaging Technologies CorporationEHA2022-12-06
D090100815230Bar, Alignment, UniversalDental Imaging Technologies CorporationEHA2022-12-06
D090100815240Bar, Alignment, EndodonticDental Imaging Technologies CorporationEHA2022-12-06
D090101114500Bar, Alignment, Bitewing, ShortDental Imaging Technologies CorporationEHA2022-12-06
D090101114510Bar, Alignment, Universal, ShortDental Imaging Technologies CorporationEHA2022-12-06
D090101115710Bar, Alignment, Endodontic, ShortDental Imaging Technologies CorporationEHA2022-12-06
D003540934B1RINN® Dentsply International Inc.EHA2022-11-27
D0035420501RINN® Dentsply International Inc.EHA2022-11-27
D0035501001RINN® Dentsply International Inc.EHA2022-11-27
D0035503221RINN® Dentsply International Inc.EHA2022-11-27
D0035506611RINN® Dentsply International Inc.EHA2022-11-27
D0035507721RINN® Dentsply International Inc.EHA2022-11-27
D0035507771RINN® Dentsply International Inc.EHA2022-11-27