FDA.report

Pressure Indicator Paste

Primary DI
D6870021101FG2
Brand
Pressure Indicator Paste
Company
DENTSPLY INTERNATIONAL INC.
Model
0021101FG
Catalog number
0021101FG
Device description
Pressure Indicator Paste 2 oz. (59mL)
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EFHPAPER, ARTICULATION

Product Code Classifications

CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6870021101FG2PrimaryHIBCC0
D6870021101FG0Unit of UseHIBCC0

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Total Volume59Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
083235549
Device count
100
DM exempt
true
Premarket exempt
true
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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