FDA.report

Contoured Wood Wedges 12mm Blue Refill

Primary DI
07540172001540
Brand
Contoured Wood Wedges 12mm Blue Refill
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
095412
Catalog number
095412
Device description
Dental wedge, single-use
Published
2020-10-21
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
07540172001540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172001540075401720015407540172001540

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length12Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags

DUNS number
626406016
Device count
1
DM exempt
true
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
false

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