FDA.report

PARAFFIN WAX

Primary DI
D080XXPRWSAMPLMLGP0
Brand
PARAFFIN WAX
Company
YAMAHACHI DENTAL MFG.,CO.
Model
SAMPLE,LARGE MEDIUM,LIGHT PINK
Published
2023-10-02
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

Product Codes

CodeName
EBHMaterial, Impression Tray, Resin
EGDWax, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D080XXPRWSAMPLMLGP0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental base plateA foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
693430001
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04582276127125CROWN PXT51, B42020-06-11
04582276127149CROWN PXT61, B42020-06-11
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04582276127460CROWN PXT61, C12020-06-12
04582276126401CROWN PXS51, B22020-06-02
04582276126449CROWN PXS71, B22020-06-02
04582276126456CROWN PXS81, B22020-06-02
04582276126463CROWN PXT41, B22020-06-02
04582276126470CROWN PXT41S, B22020-06-02
04582276126487CROWN PXT51, B22020-06-02
04582276126494CROWN PXT51S, B22020-06-02
04582276126517CROWN PXT61S, B22020-06-02
04582276127040CROWN PXS51, B42020-06-11
04582276127088CROWN PXS71, B42020-06-11
04582276127095CROWN PXS81, B42020-06-11
04582276127101CROWN PXT41, B42020-06-11
04582276127118CROWN PXT41S, B42020-06-11

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