FDA.reportPublic FDA data

Temptation NOW® A1 76g

Primary DI
07540172002042
Brand
Temptation NOW® A1 76g
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
152451
Catalog number
152451
Device description
Crown and Bridge Temporary Resin
Published
2016-09-16
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
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540172002042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172002042075401720020427540172002042

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight76Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to direct sunlight or the chairlight.
Storage Environment Temperature4 Degrees Celsius23 Degrees Celsius
Storage Environment Temperature39 Degrees Fahrenheit73 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
false
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

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07540172019132G5 All-Purpose Desensitizer2261102261102024-09-23
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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

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