FDA.report

WedgeWands®

Primary DI
00810038096360
Brand
WedgeWands®
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
WCK4
Catalog number
WCK4
Device description
Cure-Through Wedge Kit: 400 Count (100 of Each Size)
Published
2020-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EJBHandle, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810038096360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810038096360008100380963608100380963600810038096360

GMDN Terms

TermDefinition
Dental wedge, single-useA dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-437-0032gds@garrisondental.com

Regulatory Flags

DUNS number
057647005
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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00810038091280Quad Matrix System™Q500R-1Q500R-12025-02-16

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