FDA.report

Waterpik Opotow Standard Z.O.E. Impression Paste

Primary DI
D686122003
Brand
Waterpik Opotow Standard Z.O.E. Impression Paste
Company
WATER PIK, INC.
Model
012200-000
Catalog number
012200-000
Device description
Zinc oxide eugenol impression paste, Type I heavy-bodied
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EMBZinc Oxide Eugenol

Product Code Classifications

CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D686122003PrimaryHIBCC0

GMDN Terms

TermDefinition
Zinc oxide eugenol dental cementA non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Weight80Gram
Weight145Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
(800) 525-2020professional@waterpik.com

Regulatory Flags

DUNS number
001804074
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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