FDA.report

Poly Mixing Pads with Foam

Primary DI
00616784447339
Brand
Poly Mixing Pads with Foam
Company
DYNAREX CORPORATION
Model
4473
Device description
Poly Mixing Pads with Foam Back- (poly 2 side), 3"x3", Poly-coated, 100 sheets per pad
Published
2021-06-21
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

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784447339PackageGS16In Commercial Distribution
00616784447322PrimaryGS10
00616784447315Unit of UseGS10

GMDN Terms

TermDefinition
Dental material mixing surface, single-useA pad, tray, or well intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
3
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
true
Sterilization required before use
false

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