FDA.reportPublic FDA data

Henry Schein® Eugenol, USP

Primary DI
D6871710504FG2
Brand
Henry Schein® Eugenol, USP
Company
DENTSPLY INTERNATIONAL INC.
Model
1710504FG
Catalog number
1710504FG
Device description
Henry Schein® Eugenol - 4 oz bottle
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMBZINC OXIDE EUGENOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6871710504FG2PrimaryHIBCC0
D6871710504FG0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, soft, professionalA denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume4Fluid Ounce

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to temperatures above 95° F (35° C)

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
083235549
Device count
12
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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D002624551021Polytrays62455102624551022022-07-07
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