FDA.reportPublic FDA data

Evanesce™ Nano-Enhanced Universal Restorative

Primary DI
07540172011211
Brand
Evanesce™ Nano-Enhanced Universal Restorative
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
321512
Catalog number
321512
Device description
Dental Composite Resin
Published
2016-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540172011211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172011211075401720112117540172011211

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight4Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from direct sunlight
Storage Environment Temperature025 Degrees Celsius
Storage Environment Temperature078 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags#

DUNS number
626406016
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
07540172019125G5 All-Purpose Desensitizer2261052261052024-09-23
07540172019132G5 All-Purpose Desensitizer2261102261102024-09-23
07540172019514Evanesce™ Nano-Enhanced Universal Restorative A2U Single Dose Sample9732129732122024-09-17
07540172019644Evanesce™ Silk Nano-Enhanced Universal Restorative A1E Single Dose3235703235702024-09-17
07540172019651Evanesce™ Silk Nano-Enhanced Universal Restorative A2E Single Dose3235713235712024-09-17
07540172019668Evanesce™ Silk Nano-Enhanced Universal Restorative A3E Single Dose3235723235722024-09-17
07540172019675Evanesce™ Silk Nano-Enhanced Universal Restorative B1E Single Dose3235733235732024-09-17
07540172019682Evanesce™ Silk Nano-Enhanced Universal Restorative A2D Single Dose3235743235742024-09-17
07540172019699Evanesce™ Silk Nano-Enhanced Universal Restorative A3D Single Dose3235753235752024-09-17
07540172019705Evanesce™ Silk Nano-Enhanced Universal Restorative B2U Single Dose3235763235762024-09-17
07540172019712Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose3235773235772024-09-17
07540172019729Evanesce™ Silk Nano-Enhanced Universal Restorative A2U Single Dose Sample9732119732112024-09-17
07540172019507MPa Universal™ Light-Cure Universal Adhesive Unit Dose Sample9732669732662024-08-09
07540172019392EdgeDam™ Refill Heavy 6x6 Latex-FreeEDVLFH6650EDVLFH66502024-06-04
07540172019408EdgeDam™ Refill Heavy 5x5 Latex-FreeEDVLFH5550EDVLFH55502024-06-04
07540172019415EdgeDam™ Refill Medium 6x6 Latex-FreeEDVLFM6650EDVLFM66502024-06-04
07540172019422EdgeDam™ Refill Medium 5x5 Latex-FreeEDVLFM5550EDVLFM55502024-06-04
07540172019439EdgeDam™ Refill Heavy 6x6 LatexEDBLH6636EDBLH66362024-06-04
07540172019446EdgeDam™ Refill Heavy 5x5 LatexEDBLH5552EDBLH55522024-06-04
07540172019453EdgeDam™ Refill Medium 6x6 LatexEDBLM6636EDBLM66362024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967025856RodinPac-Dent, Inc.EBF2026-03-24
00815967025863RodinPac-Dent, Inc.EBF2026-03-24
00815967025870RodinPac-Dent, Inc.EBF2026-03-24
00815967021438OptiCompPac-Dent, Inc.EBF2026-03-23
00815967021797OptiCompPac-Dent, Inc.EBF2026-03-23
00815967027447RodinPac-Dent, Inc.EBF2026-03-23
00815967028161RodinPac-Dent, Inc.EBF2026-03-23
00815967028178RodinPac-Dent, Inc.EBF2026-03-23
00815967028185RodinPac-Dent, Inc.EBF2026-03-23
00815967028192RodinPac-Dent, Inc.EBF2026-03-23
00815967028208RodinPac-Dent, Inc.EBF2026-03-23
00815967028215RodinPac-Dent, Inc.EBF2026-03-23
00815967028222RodinPac-Dent, Inc.EBF2026-03-23
00815967028239RodinPac-Dent, Inc.EBF2026-03-23
00815967028246RodinPac-Dent, Inc.EBF2026-03-23
00815967028253RodinPac-Dent, Inc.EBF2026-03-23
00815967028260RodinPac-Dent, Inc.EBF2026-03-23
00815967028277RodinPac-Dent, Inc.EBF2026-03-23
00815967028284RodinPac-Dent, Inc.EBF2026-03-23
00815967028291RodinPac-Dent, Inc.EBF2026-03-23
00815967028307RodinPac-Dent, Inc.EBF2026-03-23
00815967028314RodinPac-Dent, Inc.EBF2026-03-23
00815967028321RodinPac-Dent, Inc.EBF2026-03-23
00815967028338RodinPac-Dent, Inc.EBF2026-03-23
00815967028345RodinPac-Dent, Inc.EBF2026-03-23
00815967028352RodinPac-Dent, Inc.EBF2026-03-23
00815967028369RodinPac-Dent, Inc.EBF2026-03-23
00815967028376RodinPac-Dent, Inc.EBF2026-03-23
00815967028383RodinPac-Dent, Inc.EBF2026-03-23
00815967028390RodinPac-Dent, Inc.EBF2026-03-23