FDA.report

Waterpik Original Tofflemire II Matrix Band Retainer

Primary DI
D6860611020003
Brand
Waterpik Original Tofflemire II Matrix Band Retainer
Company
WATER PIK, INC.
Model
20016455
Catalog number
20016455
Device description
Contra-Angle
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
JEPRetainer, Matrix

Product Code Classifications

CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6860611020003PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental matrix band retainerA dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. 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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