FDA.report

Waterpik Original Tofflemire Matrix Bands

Primary DI
D6863458500
Brand
Waterpik Original Tofflemire Matrix Bands
Company
WATER PIK, INC.
Model
34585-0
Catalog number
34585-0
Device description
No. 13 Pedo Universal
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
true

Related Records

Contact Domains

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6863458503PrimaryHIBCC0
D6863458500Unit of UseHIBCC0

GMDN Terms

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

TypeValueUnit
Depth0.0015Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
001804074
Device count
36
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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