FDA.reportPublic FDA data

Nuance®

Primary DI
D813CR11090
Brand
Nuance®
Company
DEN-MAT HOLDINGS, LLC
Model
CR1109
Catalog number
CR1109
Device description
NUANCE B2 UNIVERSAL SYR
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101215000NUANCEDiscus Dental, LLC2010-05-12EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D813CR11090PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects.
Special Storage Condition, Specify00Keep away from direct sunlight, extreme heat or open flame.
Special Storage Condition, Specify00Nuance FLOW should not be used past the expiration date listed on the syringe.
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D813CR11010Nuance®CR1101CR11012016-09-24
D813CR11020Nuance®CR1102CR11022016-09-24
D813CR11030Nuance®CR1103CR11032016-09-24
D813CR11040Nuance®CR1104CR11042016-09-24
D813CR11060Nuance®CR1106CR11062016-09-24
D813CR11080Nuance®CR1108CR11082016-09-24
D813CR11120Nuance®CR1112CR11122016-09-24
D813CR11210Nuance®CR1121CR11212016-09-24
D813CR11350Nuance®CR1135CR11352016-09-24
D813CR11360Nuance®CR1136CR11362016-09-24
D813CR11370Nuance®CR1137CR11372016-09-24
D813CR11380Nuance®CR1138CR11382016-09-24
D813CR11400Nuance®CR1140CR11402016-09-24
D813CR11420Nuance®CR1142CR11422016-09-24
D813CR11430Nuance®CR1143CR11432016-09-24
D813CR11460Nuance®CR1146CR11462016-09-24
D813CR11550Nuance®CR1155CR11552016-09-24
D813CR12090Nuance®CR1209CR12092016-09-24
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06

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