FDA.report

Waterpik Densco Condensaire Condenser Tip

Primary DI
D68608103
Brand
Waterpik Densco Condensaire Condenser Tip
Company
WATER PIK, INC.
Model
000810-000
Catalog number
000810-000
Device description
Medium round tip
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

Contact Domains

Product Codes

CodeName
EKGCondenser, Amalgam And Foil, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D68608103PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

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
true

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