FDA.report

Integrity® TempGrip® Temporary Crown & Bridge Cement

Primary DI
D0026664401
Brand
Integrity® TempGrip® Temporary Crown & Bridge Cement
Company
DENTSPLY INTERNATIONAL INC.
Model
666440
Catalog number
666440
Device description
Integrity® TempGrip® Syringe Evaluator Package
Published
2016-09-21
Public version status
Update
Distribution status
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
EMACEMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026664401PrimaryHIBCC0

GMDN Terms

TermDefinition
ESDP endoscopeA dedicated endoscope with a rigid inserted portion intended for the treatment of varicose veins, i.e., endoscopic subfascial dissection of perforating veins (ESDP). It is inserted through an artificial orifice transcutaneously alongside the outside of the perforating vein during the procedure. Anatomical images are transmitted to the user by the device through relayed lens optics. The varicose veins are typically cauterized by using an endotherapy device entered through the endoscope. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Weight9Gram

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.
Storage Environment Temperature8 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
083235549
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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