FDA.reportPublic FDA data

Waterpik Densco Condensaire Amalgam Condenser

Primary DI
D6860831110003
Brand
Waterpik Densco Condensaire Amalgam Condenser
Company
WATER PIK, INC.
Model
083111-000
Catalog number
083111-000
Device description
Instrument only
Published
2020-08-31
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
EKGCondenser, Amalgam And Foil, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6860831110003PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam condenser, reusableA hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(800) 525-2020professional@waterpik.com

Regulatory Flags#

DUNS number
001804074
Device count
1
Premarket exempt
true
Sterilization required before use
true

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Primary DI, Brand, Model table
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