FDA.reportPublic FDA data

Superdent® Pressure Indicator Paste

Primary DI
D6871421101FG2
Brand
Superdent® Pressure Indicator Paste
Company
DENTSPLY INTERNATIONAL INC.
Model
1421101FG
Catalog number
1421101FG
Device description
Superdent® Pressure Indicator Paste - 2 oz. - 951-8604
Published
2016-09-21
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
EFHPAPER, ARTICULATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6871421101FG2PrimaryHIBCC0
D6871421101FG0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cement trialA non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume59Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing.
Storage Environment Temperature10 Degrees Celsius33 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
100
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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