FDA.report

Articulating paper/film

Primary DI
D04060002140
Brand
Articulating paper/film
Company
WHIP-MIX CORPORATION
Model
60002
Catalog number
60002
Device description
A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.
Published
2020-08-17
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
EFHPaper, Articulation

Product Code Classifications

CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D04060002140PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental articulation paperA strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
006385173
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
false

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