FDA.reportPublic FDA data

RINN®

Primary DI
D0035525711
Brand
RINN®
Company
Dentsply International Inc.
Model
552571
Device description
XCP-ORA® Dexis Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® Dexis 4 Horizontal Bitewings with Biteblocks, 4 Vertical Bitewings with Biteblocks. XCP-DS® Dexis 4 Posterior Biteblocks, 4 Anterior Biteblocks. 50 Bulk Sensor Covers.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGZHolder, film, x-ray
EHAAligner, beam, x-ray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0035525711PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead/sensor/probe cover, non-sterileA non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature.
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-8825xx@xx.xx

Regulatory Flags#

DUNS number
795572718
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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Primary DI, Brand, Model table
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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 CorporationEGZ2026-08-03
D090101399140DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399150DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399150DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399160DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399160DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399170DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399170DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399180DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399180DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399190DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399190DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461070DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461070DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461090DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461090DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461480DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461480DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461490DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461490DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461500DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461500DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461510DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461510DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461520DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461520DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
00856145008926Two ClikrayONE Universal Holders WINE + Two G-Rings and RodsCLIKTECH LLCEGZ2026-07-17
00840456221891JMUJMU DENTAL, INCEGZ2026-06-08
00840456221907JMUJMU DENTAL, INCEGZ2026-06-08
00840456221914JMUJMU DENTAL, INCEGZ2026-06-08