FDA.reportPublic FDA data

Waterpik Original Tofflemire Matrix Bands

Primary DI
D6863457893
Brand
Waterpik Original Tofflemire Matrix Bands
Company
WATER PIK, INC.
Model
34578-9
Catalog number
34578-9
Device description
No. 1 Adult Universal
Published
2020-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6863457893PrimaryHIBCC0
D6863457890Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0.0015Inch

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
36
Premarket exempt
true
Sterilization required before use
true

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Primary DI, Brand, Model table
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00073950333924Waterpik RainFall+ with PowerPulse YPW-833EYPW-833E2024-04-29
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